QC Manager Jobs in New Jersey

Job Title: Sr. Manager, Document Process Management, Quality Control and Training Company: Eisai Inc. Location: Woodcliff Lake, NJ Description: The incumbent will be responsible for supervising Documentation and Documentation Quality Control personnel and ensuring that all clinical trial documents and associated processes (including templates and checklists) are of the highest quality and comply with relevant regulations and GCP guidelines. Primary responsibilities include:Ensuring the process for clinical trial document management is consistent across PCU’s and follows appropriate regulations and GCP guidelines. Monitoring and maintaining SOPs/SWPs/GDLs and associated forms and checklist(s) associated with Document Management. Developing and presenting Standardization portion of the Eisai-CRO Familiarization Meetings; researching, assessing, developing and implementing Best Practices with CRO representatives from preferred CRO partners; identifying/updating and maintaining Eisai SOPs for CROs to follow across studies and providing these to the CRO on an ongoing basis; identifying/updating a set of CRO standard reports to be utilized for all studies with respective CRO; regularly monitoring each CRO’s portal to ensure SOPs and standard reports are current and available; participating in CRO operational meetings. Ensuring Informed Consent Form process in eDMS is being adhered to by CO staff; Ensuring all staff that create, review & approve ICF documents are trained; Keeping ICF template up to date in eDMS; Participating on initiatives to improve the ICF template and/or create additional ICF templates. Managing the quality control review of clinical trial documents across PCU’s to identify inconsistencies thereby reducing errors prior to submission to domestic and international regulatory agencies. Prioritizing and managing quality control reviews to meet project timelines. Coordinating with PhlexGlobal to ensure management of the QC module with respect to identification of studies and study staff needing access and ensure staff is appropriately trained. Effectively communicating document management and quality issues along with potential solutions to project teams and management. Providing feedback for correction and resolution to appropriate internal and external personnel. Exploring ways to standardize and streamline study start-up activities. Developing and coordinating ClinTrain curriculum and training sessions with Process Development and HR Training Departments to ensure a consistent approach is utilized across PCU’s; managing and maintaining the training matrices across Eisai Product Creation Systems; ensuring global harmonization and consistency of training matrices. In collaboration with PCUs, reviewing, collect input on and writing departmental SOPs/SWPs/GDLs, templates or forms, as needed. Identifying, developing, and implementing process improvements.

Job Title: Manager, Quality Control - Micro Company: Dendreon Corporation Location: New Brunswick, NJ Description: Manager, Quality Control - MicrobiologyJob Type: Regular Full-TimeLocation: Morris Plains, NJJob Description:Dendreon is seeking a Manager, Quality Control for our New Jersey Microbiology Laboratory, Night Shift operations. This is an exciting position accountable for providing leadership, management and delivery of compliant laboratory data in support of Dendreon's products and in accordance with appropriate regulatory, corporate and scientific guidelines. The successful candidate will manage the Microbiology Laboratory operations on a daily basis, as well as during inspections/audits by the FDA and other regulatory agencies. This person leads, develops and mentors reporting staff at a variety of levels. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.General Summary:* Manages operations in the Microbiology Laboratory.* Oversees microbiological tests performed during in-process and final product testing of Dendreon products.* Monitors sample collection, testing, and data review.* Manages test samples, reagents and reference standards in the Microbiology Laboratory.* Conducts and manages laboratory investigations, participates as QC representative during investigations into deviations/exceptions and environmental monitoring excursions.* Ensures laboratory data integrity and traceability.* Communicates with Corporate QC and ensures implementation of harmonized laboratory control systems in the NJ Microbiology Laboratory.* Participates in planning and process improvement activities at the departmental and inter-functional level.* Sets goals, and conduct performance reviews of direct reports; performs ongoing assessment of development and training needs of reporting staff to ensure continued development of personnel.* Contributes to the development of department budget and monitors expenditures.Job Requirements:* B.S. degree in Microbiology, or other relevant scientific discipline.* 7 years of experience in a cGMP Quality Control department in a FDA regulated industry (drugs/biologics) with at least 3 years in a leadership role; commercial phase experience required.* Thorough knowledge of cGMP/ICH/FDA regulations.* Experience with inspections/audits by the FDA and other regulatory agencies.* Experience with LIMS preferred.* Ability to prioritize and successfully manage complex and competing projects.* Proficient in MS Office applications.Working Conditions and Physical Requirements:* Limited travel required.* Limited handling of laboratory equipment, chemicals and biological materials.The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: Senior Quality Control Manager Company: Kforce Technology Staffing Location: Jersey City, NJ Description: .mainbody .RightColumn .LeftColumn a .jlocation .jdetail .jtitle .jdescription .jFontstyle14 .jFontstats .jFontstyle13 .jFontstyle16 .jFontstyle17 .position .jFontstats Status: Full-Time, Employee Level: 2-5 Years Experience Job Location: Jersey City, NJ Job Ref Code: ITAQG971326 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . About Kforce Technology . . . . . . . . . . . . . With over 45 years of experience, Kforce continues to set the standard in the technology staffing & solutions industry. With an unwavering commitment, Kforce strives to provide candidates with exceptional service in meeting their employment and career needs. Kforce provides consulting, contract-to-hire or direct hire positions with a wide range of organizations; from small, privately held companies to large, multinationals. Our technical specialty areas include: data management, functional and business analysis, infrastructure and systems application development. . Backed by approximately 1,900 staffing specialists, Kforce is committed to "Great People = Great Results" for our valued clients and candidates. Our Firm operates with 62 offices in 41 markets in North America and two in the Philippines. Kforce is an EEO/AA Employer . POSITION Senior Quality Control Manager . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Job Description: Our client, located in Jersey City, is seeking a Senior Quality Control Manager to be responsible for managing a globally distributed quality assurance team assembled from both employees and vendors. The individual will be the primary Quality Control Manager on a Premier Global Corporate internet-based Cash Management System. This candidate must have a background on managing a large Quality Control organization. Primary Responsibilities: Define and/or review the test environment planning and requirementsDefine and/or conduct training for the Quality Control Testers and LeadsReview and approve business requirements to ensure quality of requirementsDefine forecast and manage budgets for new / existing applicationsCreate and define resource plans for Quality Control projects and applicationsProvide coordination for all special (post-production validation, etc.) testing activitiesDefine and ensure adherence to quality standards for the software organizationSecondary Responsibilities: Choose, implement, and define the usage of testing toolsProvide ultimate sign-off for all deployments in the UAT or production environmentsChoose which applications (and to what extent) are candidates for automationDefine coverage plans for weekend release supportEnsure code coverage and traceability to requirements and defectsSpecific Qualifications (items are required unless noted otherwise): Experience with managing quality programs on large scale Internet application testing6+ years as a Quality Control Lead or ManagerAbility to provide global guidance to regional quality control processAbility to set-up global / regional program quality control processAbility to support UAT and/or client test teamsBanking or financial knowledgeExperience in managing SOA application testing is a plusPrevious experience with LoadRunner or automated testingKnowledge of CMM / CMMI or other process improvement methodologies is a plusCollege degree in a Business or Technology field; a Bachelor of Science or Arts degree in an Engineering or Computer Science field is preferredProfessional affiliation with ASQ or other quality organizations is a plusInterpersonal and Leadership Competencies: Ability to work well and respect other disciplines of the project teamsStrong negotiation and influence skillsAbility to manage risk appropriatelyAbility to thrive in a team-oriented, fast-paced environmentExcellent technical written and verbal communication skillsAbility to prioritize individual and team tasks and projects so that deadlines are metAbility to work on multiple deliverables at once and appropriately manage your timeThis position pays 125000.00-175000.00 annuallyApply for this job Great People = Great Results

Job Title: Mgr, Quality Company: Siemens Location: Flanders, NJ Description: '); } } checkframes(); Skip Navigation Job Details Mgr, Quality Company Siemens Healthcare Diagnostics Inc. Division SMSD - IVD OPS Functional Area QC - Quality Location NJ - Flanders Req ID 85016 Job Type Regular Job Time Full-Time Experience Level Senior Level Required Education Bachelors Degree Required Travel 20% Company Description Siemens Healthcare Diagnostics Inc.  offers a broad portfolio of performance-driven diagnostic solutions that provide more effective and efficient ways to anticipate, diagnose, monitor and treat disease.  Our products and services offer the right balance of science, technology and practicality across the healthcare continuum to provide medical professionals with the vital information they need to deliver better, more personalized healthcare to patients around the globe.  Visit us at www.siemens.com/diagnostics. Siemens is an Equal Opportunity Employer encouraging diversity in the workplace. Job Description Responsible for developing and coordinating quality focused activities to monitor and improve Instrument products and processes. 2.             Responsible for supporting decision making process concerning part/product performance issues and ensuring appropriate investigation, documentation and notification to internal personnel, as required. 3.            Responsible for the handling and management of the Supplier Quality Assurance and Final Product Release activities. 4.            Staff and develop the Supplier Quality Assurance and Final Release functions. 5.            Budget and administer expenditures for the group. 6.         Responsible for developing & strengthening Supplier Quality Programs.   7.       Interact routinely with Purchasing, Engineering & Suppliers to proactively improve quality of components. 8.     Responsible for understanding the Quality Management System. 9.     Incumbent needs to integrate their knowledge of the quality policy and business objectives into their work practices to augment the business such as: participating in internal audits, identifying areas which need improvement, implementing plans to correct and prevent problems. 10.  A key responsibility of this position is to ensure that their area of responsibility is in compliance with the FDA, ISO and IVDD standards Qualifications ·          Bachelor’s Degree in Engineering or relevant field and Certified as a Quality Auditor or a Certified Quality Manager; or the equivalent in related work experience. ·          Minimum of 5-8 years of professional level experience in a manufacturing operation. ·          Previous experience in a FDA and/or ISO regulated environment necessary. ·          Requires excellent facilitation and communication skills, both oral and written. ·          Needs to be able to exercise independent judgment to determine project guidelines purpose follow-through, and completion. ·          Ability to effectively work with all levels of employees and business representatives from other organizations. ·          Supervisory Ability - Managing and Developing Subordinates – expected to be able to provide challenging tasks and assignments with the appropriate degree of empowerment; is a people builder.  Able to act as a mentor and provide on-going constructive feedback.

Job Title: Manager, Quality Control Bioassa Company: Dendreon Corporation Location: New Brunswick, NJ Description: Manager, Quality Control Bioassay - Alt ShiftJob Type: Full-Time 10 p.m. - 8 a.m.Location: Morris Plains, NJJob Description:Dendreon is seeking a Manager for our New Jersey Bioassay Laboratory night shift operations working the hours of 10 pm - 8 am. This is an exciting position accountable for providing leadership, management and delivery of compliant laboratory data in support of Dendreon's products and in accordance with appropriate regulatory, corporate and scientific guidelines. The successful candidate will manage the Bioassay Laboratory operations on a daily basis, as well as during inspections/audits by the FDA and other regulatory agencies. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. This person leads, develops and mentors reporting staff at a variety of levels.General Summary:* Responsible for the management of daily operations in the Bioassay Laboratory.* Responsible for in-process and final product testing of Dendreon products.* Manages test samples, reagents and reference standards.* Conducts and manages laboratory investigations, and participats as QC representative during investigations into deviations/exceptions and non-conformance materials.* Manages laboratory equipment.* Ensures laboratory data integrity and traceability.* Communicates with Corporate QC and ensures implementation of harmonized laboratory control systems in the NJ Bioassay Laboratory.* Participates in planning and process improvement activities at the departmental and inter-functional level.* Sets goals, and conducts performance reviews of direct reports; performs ongoing assessment of development and training needs of reporting staff to ensure continued development of personnel.* Contributes to the development of department budget and monitors expenditures.Requirements:* Bachelor's degree in biology, medical technology or equivalent.* Typically 7 years of related experience in a cGMP Quality Control department in an FDA regulated industry (drugs/biologics) with at least 3 years in a leadership role; Commercial phase experience required.* Thorough knowledge of cGMP/ICH/FDA regulations.* Experience with inspections/audits by the FDA and other regulatory agencies.* Experience with LIMS preferred.* Ability to prioritize and successfully manage complex and competing projects.* Proficient in MS Office applications.Working Conditions and Physical Requirements:* Limited travel required.* Limited handling of laboratory equipment, chemicals and biological materials.The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: Manager, Quality Management - PHARMA ONLY Company: Alternative Resources Company Location: Piscataway, NJ Description: Role Title: Manager, Quality Management Department/Group: Quality Management Career Level: S/P3 Supervisor: Director – Quality Management Date:  February, 2010 Position Overview Assesses and communicates the state of clinical trial and drug manufacturing activities with regard to Regulatory compliance to QM Director. Provides review, guidance and oversight to assure company activities are in compliance with regulatory requirements, industry standards and corporate objectives/mandates. Essential Job Responsibilities/Primary Activities Provides quality control and assurance review of submission documents which includes (but is not limited to) the following: all submission documents such as INDs, NDAs, IB, protocols, annual reports, informational amendments, etc. to ensure that documents are written in compliance with regulations, guidelines, SOPs and other procedural documents Assists with planning audits and conducting external/internal compliance audits which includes (but not limited to) the following: investigator sites, vendor audits (CROs, Phase I units, Clinical Labs, internal system audits etc.). Serve as lead auditor, as assigned, in multi-auditor situations and authors audit reports which meet industry standards, company expectations, and require minimal input by Supervisor. Develops, implements and manages process for audit reports, responses, communication of significant audit observations as well as evaluate the adequacy and completeness of corrective and preventative action plans, and follow-up to closure as required. Accountable for reporting to QA management on the accuracy, quality and integrity of activities and processes respectively conducted and implemented within Clinical/Clinical Operations. Contribute to process improvement initiatives across the organization such as (but not limited to): assisting in the CAPA program and assist in facilitation of the CAPA plan, present audit results to various client groups, and verify corrective action implementation. Provides consultative support to internal staff on issues relating to GXP, such as GMP, GLP, GCP and computer system, compliance topics. Conducts peer review of internal and contracted audit reports as needed. Active participant to promote global harmonization, including development and technical support of global audit database and creation/review of standard operating procedures. Maintain up-to-date working knowledge of national regulations, guidelines, industry standards related to performance of clinical trials in the Americas, and may train on standard operating procedures and work instructions, GCP, compliance, auditing, etc. May recommend audits for QM audit plan and communicate audit results and associate relevant regulatory risk to Clinical teams. May assist Director with regulatory authority inspection and other types of audits as needed. Performs other department duties as assigned. Qualifications n Degree in Life Sciences Required: Bachelors  Preferred: n Minimum 4 years experience as an auditor in Clinical Research n Knowledge of GXPs with emphasis on GCP experience n Understanding of clinical development process Career Map Framework General Profile n Has in-depth experience, knowledge and skills in own discipline n Uses relevant practices and knowledge to develop products, processes, etc. n Solves moderately complex problems; takes a new perspective on existing solutions n Works independently with minimal guidance n Acts as a resource and mentors others with less experience; may project manage small teams, within and outside of own department; may have global scope Career Map Framework Dimensions (Detailed descriptions of career level dimensions) Expertise Scientific/ Professional Expertise n Has in-depth experience, knowledge and skills in own discipline n Uses current relevant practices and knowledge of internal/external scientific/professional issues to develop and improve products, services or processes in own discipline Regulatory Compliance n Develops the internal compliance environment, e.g., reviewing and revising SOPs n May oversee and ensure compliance and regulatory expectations within scope of projects or teams Delivering Solutions Problem Solving n Solves moderately complex problems; takes a new perspective on existing solutions Customer Focus n Interprets internal/external customer needs, assesses requirements and identifies solutions to non-standard requests Impact Influence n Explains difficult issues and works to establish consensus Decision Making n Makes operational decisions affecting product, processes, services Resource Management Project Management/ Coordination n Acts as a resource and mentors others with less experience; may project manage small teams, within and outside of own department; may have global scope n May forecast and plan resource requirements Financial Management n Monitors and controls costs within own work and costs for department n Makes recommendations to budget Debra Pohl President, Pharmaceutical Recruitment Alternative Resources Company Register to View

Job Title: Director QC Analytics - Quality Control - AD Quality Analysis- Associate Director QC - Sr Director Company: CyberCoders Location: Morristown, NJ Description: Director QC Analytics - Quality Control - AD Quality Analysis- Associate Director QC - Sr Director .body .body h4 .body .section tr.oddRow a, a:link, a:visited Director QC Analytics - Quality Control - AD Quality Analysis- Associate Director QC - Sr Director near Morristown, NJ This job is open as of 2/20/2010. Apply Now! Not a fit for this job? Search other Director QC Analytics jobs! Are you an employer? Visit us for more info! Email this job to a friend - $1000 Location Morristown, NJ; Plainfield, NJ Salary $140,000 - $175,000 Education PhD Category Pharmaceutical Experience Required At least 2 Years Short Description Director QC Analytics - Quality Control - AD Quality Analysis- Associate Director QC - Sr Director Required Skills QC, AD Quality Analysis, Director Quality Control Analytics, QC Testing, Bulk API, Author CMC sections, Regulatory Filings, manage CRO Laboratories, quality testing, clinical supplies Recruiter Erin Beagle Date Updated 2/20/2010 Skills Required QC, AD Quality Analysis, Director Quality Control Analytics, QC Testing, Bulk API, Author CMC sections, Regulatory Filings, manage CRO Laboratories, quality testing, clinical supplies Job Description Director Quality Control Analytics - QC - AD Quality Analysis - Associate Director QC - Sr DirectorIf you are a Director Quality Control Analytics, with a PhD, 10-15 years of experience in the pharma industry, at least 7 years analytical development/QC experience developing biological products, and you live in New Jersey, please read on!What you need for this position:-PhD in Chemistry, Biochemistry, Pharmaceutical Science or related-10-15 years experience working in a pharmaceutical company-7 years analytical development/QC experience developing biological products-Working knowledge of Development requirements for pharma API's and Dosage forms-Development experience implementing analytical Quality Systems and successful Regulatory filings-Excellent Communication skills!!!-MUST have experience managing project activities with labs and manufacturing facilities around the country/world.What you'll be doing:-Directing ALL analytical aspects of biological and small molecule projects to support US/Global drug development programs-QC testing for development batches, clinical supplies and commercial materials at contract test laboratories-Lead and direct all aspect of QC testing and reporting for commercial dosage forms, bulk API and intermediates at labs-AUTHOR and direct the assembly of specific CMC sections of regulatory filings with CRO labs, experts and manufacturing facilities-What's in it for you:-EXCELLENT salary, stock options, bonus structure-Excellent teamwork environment-Company stresses a healthy work-life balanceSo, if you are a Director Quality Control Analytics, with a PhD, 10-15 years of experience in the pharma industry, at least 7 years analytical development/QC experience developing biological products, and you live in New Jersey, please apply today!Must be authorized to work in the United States on a full-time basis for any employer. Are you a fit for this position? Please Click Here to Apply! (your information will be kept strictly confidential!) Not a fit for this position? Click Here to Search Other CyberCoders Jobs! Looking forward to receiving your resume through our website and going over the position with you. Clicking apply is the best way to apply, or you may also: Email your resume in Word to: Register to View **Please do NOT change the email subject line in any way. You must keep the JobID: CC HotJobAp : EB-QCAnalyticsDir -- in the email subject line for your application to be considered.*** Erin Beagle - Executive Recruiter - CyberCoders Other Jobs

Job Title: Manager - IT Project and Process Quality Management Company: KPMG Location: Montvale, NJ Description: At KPMG we run our firm just as effectively as we support and strengthen our clients' businesses. That means hiring talented people to help develop and manage our brand, publish our thought leadership, control our finances, run our IT infrastructure, and support our professionals in the field. There are great opportunities to build your career within our business. KPMG is a great place to build your career. We are currently seeking Managers, IT Project and Process Quality Management to join us in our Montvale office.Responsibilities: • Plan, document, and implement the Project and Process Quality Management (PPQM) process, promoting an environment that encourages identifying and reporting quality issues• Assess project activity and project management work products throughout the lifecycle to provide early detection of improvement opportunities and recommend corrective actions that comply with process requirements and quality standards• Act as the steward for the PPQM discipline, provide ongoing quality management content leadership, and establish quality management processes and tools• Maintain quality templates, process guidelines, and sample artifacts• Develop project Quality Assurance (QA) plans, analyzing risks to determine PPQM strategies, leverage project team process maturity to minimize PPQM tasks, and establish clear assessment criteria including frequency, methods, metrics, and project personnel involvement• Mentor project teams on self-assessment strategies to address noncompliance issues• Identify and document noncompliance issues and escalate those that cannot be resolve• Collate compliance performance metrics and generate status and dashboard reports for project teams and leadership• Prepare and deliver PPQM process training sessionsQualifications:• Five years of progressive Information Technology(IT) full project lifecycle methodology experience with an emphasis on process quality, compliance, and process improvement • Strong track record of performing process and product quality assurance and compliance assessments that achieved process improvement goals• Bachelor's degree from an accredited college/university• Experience with full SDLC, infrastructure, and project methodologies, processes, and best practices such as custom development, COTS implementation, requirements development and testing, PMBOK, Prince2, ASAP, Agile, Scrum• Strong knowledge of quality standards such as Six Sigma, ITIL, and CMMI; certification preferred• Excellent verbal and written communication skills with the ability to interact with all levels in an organizationKPMG offers and supports flexible work arrangements as well as part-time schedules. We also offer a comprehensive compensation and benefits package.Interested? We strongly encourage you to apply online at www.kpmgcareers.com and search for requisition 20847 or click the job link below.Follow us on Twitter:http://twitter.com/KPMGhttp://twitter.com/KPMGUSCareersKPMG. A great place to build your career.No phone calls or agencies please.KPMG Affirmative Action, Equal Opportunity Employer, M/F/D/V. KPMG maintains a drug-free workplace.© 2009 KPMG LLP, a U.S. limited liability partnership and a member firm of the KPMG network of independent member firms affiliated with KPMG International, a Swiss cooperative. All rights reserved.

Job Title: Manager, Quality Control Bioassay - Alt Shift Company: Dendreon Corporation Location: Morris Plains, NJ Description: Dendreon is seeking a Manager for our New Jersey Bioassay Laboratory night shift operations working the hours of 10 pm - 8 am. This is an exciting position accountable for providing leadership, management and delivery of compliant laboratory data in support of Dendreon’s products and in accordance with appropriate regulatory, corporate and scientific guidelines. The successful candidate will manage the Bioassay Laboratory operations on a daily basis, as well as during inspections/audits by the FDA and other regulatory agencies. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success. This person leads, develops and mentors reporting staff at a variety of levels. General Summary: Responsible for the management of daily operations in the Bioassay Laboratory.Responsible for in-process and final product testing of Dendreon products.Manages test samples, reagents and reference standards.Conducts and manages laboratory investigations, and participats as QC representative during investigations into deviations/exceptions and non-conformance materials.Manages laboratory equipment.Ensures laboratory data integrity and traceability.Communicates with Corporate QC and ensures implementation of harmonized laboratory control systems in the NJ Bioassay Laboratory.Participates in planning and process improvement activities at the departmental and inter-functional level.Sets goals, and conducts performance reviews of direct reports; performs ongoing assessment of development and training needs of reporting staff to ensure continued development of personnel.Contributes to the development of department budget and monitors expenditures. Requirements: Bachelor’s degree in biology, medical technology or equivalent.Typically 7 years of related experience in a cGMP Quality Control department in an FDA regulated industry (drugs/biologics) with at least 3 years in a leadership role; Commercial phase experience required.Thorough knowledge of cGMP/ICH/FDA regulations.Experience with inspections/audits by the FDA and other regulatory agencies.Experience with LIMS preferred.Ability to prioritize and successfully manage complex and competing projects.Proficient in MS Office applications. Working Conditions and Physical Requirements: Limited travel required.Limited handling of laboratory equipment, chemicals and biological materials. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Job Title: System Test Manager, Quality Control – INCREDIBLE OPPORTUNITY Company: MRINetwork Location: Princeton, NJ Description: System Test Manager, Quality Control – INCREDIBLE OPPORTUNITYJob Description:The System Test Manager is responsible for the verification and validation of our Software product for beta or general availability release. This position interfaces with Product Development and Product Management and reports to the VP of R&D.Lead and manage a co-located System Test team (US and India)Primary Responsibilities:Communicate and collaborate within the development environment and potentially with customers Demonstrate a high proficiency in Software Testing methods and practical experience Demonstrate a high proficiency in Automated Software Testing and Performance Testing Manage the development and execution of software test plans and to meet product requirements for software functions. Formalize, define and execute on an approach to regression testing. Create and manage and an active software quality metrics program to inform release readiness decisions and to monitor and report on post-release product quality. Coordinate software test activities with other organizations that may be involved with Alpha or Beta types testing. Manage the testing activities of multiple projects/releases at any given time. Develop, execute and maintain a software automation program to be the primary driver for regression testing Develop, execute and maintain a performance benchmarking program to load and stress test the software ensuring satisfactory performance. Play an active input and advisory role in determining release readiness of software.Skill/Requirements:Experience with Test-Driven Development, Continuous Integration and other Agile practices Understanding of good development and testing practices Exposure to Quality standards such as ISO 9000/9001 Exposure to the Life Sciences and/or highly regulated industry domain Exposure to CFR 21 Part 11 regulations Bachelor's degree in Computer Science, Computer Engineering, Electrical Engineering, or related discipline. Minimum 8 years of industry experience managing a System Test team in the software industry Minimum 10 years of industry experience in some capacity of the software development lifecycle.If you have testing experience, please email a word document of your resume to Register to View . In the body of the email, please outline your background as it relates to the job description.Visit www.kleinhersh.com to view additional job opportunities available through our company.