QC Director Jobs in Massachusetts

Job Title: QC Manager Company: Location: New Bedford, MA Description: Looking for Quality Control Manager with significant experience in all facets of scallop processing. Both in Frozen and Fresh scallops. Candidates must have good communication skills, thorough knowledge of scallops from the boat to processing to packing and shipment control. Multi-lingual English/Spanish a plus. All inquiries are strickly confidential. ALL inquiries must be made through EMAIL ONLY. Candidates will be contacted within a week.

Job Title: Director Quality Engineering Company: BD Location: Billerica, MA Description: Company Name: BD Director Quality Engineering-QUA100GM Description The Director of Quality Engineering is responsible for leading quality activities in support of new product development projects for a business platform within the Diabetes Care Business Unit. The Director of Quality Engineering will serve as a functional representative on the business platform leadership team and will be responsible for design, modification and implementation of the quality system requirements to support platform needs. The individual in this position will be responsible for developing quality objectives in support of the business platform and determining resource needs and capabilities needed to support the execution of those objectives. The scope of the quality engineering function includes product and process design, verification and validation activities, risk analysis, as well as all other aspects of design control and other applicable regulations. KEY Responsibilities: * Continually assess and modify Diabetes Care Quality System to align with the business platform needs, applicable regulatory and BDX requirements. * Recruit, manage and develop capable, competent and flexible quality engineering organization in support of the business platform needs. * Ensure that all product development projects within the business platform are executed in compliance with Diabetes Care quality system and applicable World-Wide regulations. * Ensure robust execution of the design verification, validation, risk management, and process validation activities are carried out for all aspects of product development activities within the business platform. * Responsible for integration and alignment of quality functional activities across multiple sub-projects within the business platform. * Define appropriate quality requirements and manage key contractors and suppliers contracted in support of the business platform. * Set-up and manage quality agreements with key suppliers and contractors in support of the business platform. * Responsible for performance management and career development of the Quality Engineering group in support of the platform. Qualifications Education: * Minimum of a Bachelors Degree in science or engineering. * Advanced degree / MBA a strong plus. * Certifications in related QE subject matter (ie: CQE, CQM, DFSS, Six Sigma, etc.) a strong plus. Experience: * Minimum of 5 years experience in a quality management role in a regulated medical device industry with focus on design, development and commercialization of new products and technologies. Expert in Design Control implementation and execution. * Experience with complex medical devices containing biologics, software and hardware, implantable devices is a strong plus. * Minimum working experience of 10 years working in a Medical Device regulated environment in compliance with WW regulations. Knowledge and Skills: * Demonstrated technical understanding of the various Quality Sciences that fall within the scope of the QE Functional responsibilities. * Demonstrated ability to build and manage highly motivated, competent and experienced quality engineering organization and to foster a team-oriented approach. * Thorough understanding of regulatory requirements to support PMA and IDE filings. * Experience in managing complex relationships with key co-development partners, suppliers, contractors and customers. * Prior experience in handling and processing of biologics (proteins), aseptic processing and terminal sterilization. * Prior experience, knowledge and understanding of software validation. * Prior experience with high volume manufacturing of disposable medical devices. * Understanding of IVD requirements for medical devices. * Proven ability to communicate, influence and educate other functions in quality engineering methodologies. * Strong customer focus, highly organized, responsible, and detail oriented. * Effective written and verbal communication skills. * Ability to prioritize and process high volume of work while maintaining the highest quality. * Must be able to identify and resolve problems and requests in a proactive and timely manner. * Must be able to gather, analyze and exchange information skillfully. * High level of professionalism. * Self-starter with the desire and ability to take initiative on projects. * Demonstrated ability to work independently under time constraints and to manage competing priorities and deadlines efficiently. * Proven ability to work as a part of a complex multi-functional organization. * Must be able to travel up to 15-20% of time as necessary. Job Quality Management Primary Location US-Massachusetts-Billerica Shift First Shift / Day Job Relocation Available Yes Nearest Major Market: Boston Job Category: Engineering, Scientific, Engineer, Quality Engineer, Medical Device Engineer, Finance, Risk Management, Healthcare, Diabetes, Medical Device, Special Medicine, Medical Research, Human Resources, Performance Management, Legal, Law, Compliance, Management, Six Sigma, Manager, MBA, Quality, Quality Manager, QA, Quality, Research, Research, Product Development, Technology, Quality Assurance Job Code: 900783

Job Title: Director, Quality Compliance Company: Genzyme Location: Allston, MA Description: Perform monitoring duties as directed by the Senior Director Quality for some or all of the responsibilities listed below: Monitoring the Allston Facility, including employees on all shifts, to ensure performance and operations in accordance with applicable laws and regulations including, but not limited to, quality assurance and quality control functions. Review of production, maintenance, material control and storage, and testing operations including training and qualifications of employees. Monitoring to ensure that there are procedures available and that they are continuously followed. Provide assistance as necessary to Quantic and Genzyme in the mitigation of issues. Escalation of issues to the attention of Senior Director, Corporate Product Quality Monitor as required. Ensure coordination of Consent Decree Remediation Commitments with on-going internal efforts to create Genzyme Quality System standards and processes. Verification of CAPA to prevent future occurrences of product quality deviations and completion of regulatory commitments for the Consent Decree Work Plan. Review and approve any changes related to implementation of GQS activities in Allston (except those changes which are covered by the Change Control Protocol) to SOPs to ensure congruency with GQS KPC and Standards. Review of reports and meeting minutes of discussions from the various committees and teams related to the Consent Decree. Implementation, coordination and maintenance of GQS metrics for inclusion in the quarterly report. Member of various Consent Decree Committees including but not limited to GQS Governance and Operations Team, Development Team Product Quality / Process Control Strategy Team, Validation Summit Team, Engineering Practices Team, etc. Working closely with the independent expert or auditor in order to provide for input to the quarterly reports. Additional responsibilities and generation of ad hoc reports as directed by the Senior Director Quality, Corporate Product Quality Monitor; Accountabilities / Deliverables Provide input for the establishment and maintenance of SOPs for the implementation and verification of corrective actions to prevent future occurrences of product quality deviations; Provides input each quarter for the quarterly report which includes but is not limited to the following: Adverse issues and trends. The effectiveness of CAPAs. The status of the GQS design and performance; The risks associated with issues identified; Ad hoc reports as directed that include any adverse findings and how they are to be promptly and appropriately addressed. Maintain copies of all reports and supporting data in a separate file at the Allston Facility which is immediately available for FDA inspection upon request; NOTES: North American Residents Only

Job Title: QC Manager Company: Location: Worcester, MA Description: Quality Control Manager Machine Tool, Manufacturing Company Extensive knowledge in Machine Shop/Manufacturing Environment Direct Position

Job Title: Director, Quality and Regulatory - MNL Company: Medtronic Location: Littleton, MA Description: The Director of Quality Assurance and Regulatory Affairs will have the key responsibility for Medtronic Navigation Littleton's quality and regulatory strategy. This dynamic individual will provide strategic direction and leadership, drawing upon his/her deep and broad business experiences to create a custom, world-class quality and regulatory function for the company.Position ResponsibilitiesStrategic Planning & Leadership: Serving as a member of the MNL leadership team, work with Site Director and peers to craft and communicate the vision, and contribute expertise that will influence the formation of strategic and operating plans to ensure successful growth of the Medical Imaging business. Proactively counsel throughout Medtronic Navigation regarding quality and regulatory matters Aggregate and manage Medtronic Navigation's relationships with the FDA, TUV and other external regulatory agencies ensuring a common vision and best practices approach; liaise with the FDA and other global regulatory agencies to ensure all reporting requirements are met Serve as the management representative for the Medtronic MNL Quality System, developing and implementing a best-practices approach to quality systems to create a sustainable culture of quality Establish innovative quality and regulatory compliance programs and infrastructure that will set the standard in proactively responding to legal, regulatory or other environmental factors that will influence the design and manufacturability of Medtronic Navigation products Lead the regulatory approval process for all products in development and within all applicable markets globallyOrganizational Consulting/Change Management: Assess current competencies and problem areas; collaborate with MNAV leadership to problem solve and provide support and solutions aligning resources with business objectives Partner with functional leaders to develop and implement integrated quality plans in support of business strategy; provide quality perspective to strategic planning and the long-range Product Development plans. Build and develop global quality team into a cohesive, credible organization recognized for expertise and thought leadership able to deliver value-add contributions to the business Encourage strategic/systemic thinking; promote and reward innovation, effectiveness, efficiency and continuous improvement to design quality products that address specific market and customer needs Establish a culture of partnership, transparency and collaboration in support of business and corporate objectives; ensuring that the quality organization is truly able to track the "pulse" of the organization to identify blind/weak spots that could potentially derail/delay objectivesInfrastructure Development: Devise and implement the vision and strategy for global design of quality programs and organizations Work with Quality and worldwide leaders to design and approve Medtronic quality protocols; ensure effective adoption, implementation and review of quality programs, working through others to gain buy-in/ownership of initiatives Provide leadership to the corporate and worldwide quality organization; ensure appropriate quality and quantity of resources to meet and exceed quality standards, develop, support , and lead budgeting process to ensure appropriate level and use of resources Develop core quality competencies and capabilities in all business units and geographies; assess competency gaps as well as training/recruiting needs, prioritizing the development of competencies to match aggressive business initiatives on a global basis Directs the Quality System audit and Corrective Action programs within MNL, ensuring timely and appropriate responseOperational Oversight/Quality Stewardship: Provide direction to the quality curriculum for MNL leadership, customers and employees to promote a "culture of quality" in every thought and facet of business operations Establish and lead periodic management reviews of quality systems (people, infrastructure, tools and training), ensuring that Quality System is planned, understood, implemented and maintainedBasic QualificationsEDUCATION REQUIRED B.A./B.S. in Engineering, Scientific, or related fieldYEARS OF EXPERIENCE 10+ years in business and corporate quality function within medical technology company, with track record of success in dynamic organizations. 8+ years senior leadership experience; this individual must be credible as a leader and able to inspire others, creating a dynamic environment that fosters innovation in thought and execution, as well as collaboration and transparency; must be able to build a broad and effective teamSPECIALIZED KNOWLEDGE REQUIRED Track Record: Proven track record of accomplishments and innovation establishing progressive quality organizations and programs; in-depth knowledge and expertise in leading-edge quality programs and all applicable federal and international regulations Business Savvy, Solution-oriented "Architect": High-energy, accountable and forward-looking; able to see larger business picture to identify and diagnose problems and craft solutions Culture Creation: Dynamic individual with the ability to shape culture and drive quality ownership and stewardship through building a comprehensive, best-in-class quality organization and strategy to align with business objectives Strategic Thinker/Change Agent: Persuasive individual with the ability to work at leadership and all levels to educate and gain buy-in for all programs and initiatives Coach & Captain: Must be able to effectively challenge and influence others to have functional and geographic leaders "own" vision and strategies; must be an approachable and trusted confidant, able to encourage confidence to receive 'unfiltered truth' about potential problems at all levels; lead and manage quality function and staff, as well as peers on programs and initiatives Drive/"Gets it done" Attitude- this individual must be a "working manager" and practical thinker, able to identify and devise realizable solutions and roll-up his/her sleeves to get things done; he/she must also be able to identify and alleviate any potential hurdles to achieving objectives, successfully managing people and projects, both directly and through influenceDesired/Preferred Qualifications MBA/Masters Degree Strong understanding of Medical Capital Equipment Knowledge of Regulatory Requirements for radiation producing equipment Medical Imaging experience desiredPhysical Job RequirementsPHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, sit, walk, talk, hear and reach with hands and arms. The employee frequently is required to use hands to finger, handle, or feel objects, tools, or controls. Specific vision abilities required by this job include normal vision.WORK ENVIRONMENT:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet to moderate.

Job Title: Manager Quality Control Company: Genzyme Location: Allston, MA Description: Genzyme Corporation, ranked as one of the foremost biotechnology companies in the world, is committed to providing an exceptional environment in which individuals can excel, and achieve their professional and personal goals. Genzymes people and culture have been consistently recognized for excellence. For example, we have been named several times to Fortunes list of the 100 Best Companies to Work For in the United States. We also consistently rank among the top employers for scientists in surveys of Science readers. Genzymes local offices and facilities in Europe and other parts of the world have earned similar distinction as respected employers. By applying for a position with Genzyme, you are taking the first step toward becoming a part of our dynamic and talented team, and sharing in our continued success.Manager Quality ControlThis individual will be responsible for providing leadership and technical management within the Allston Landing Facilitys Microbiology Department. The duties include meeting project, business, scientific and compliance objectives and company goals. A proven record of successfully managing Microbiology groups in a pharmaceutical/biotech environment is required. The incumbent should have demonstrated experience in contamination investigations, aseptic controls, and new microbial technology. They will provide microbiology support to the manufacturing of mammalian Cell Culture, Downstream Purification, and Sterile Fill as well as Validation and Quality. The incumbent will actively promote safety rules and awareness, will demonstrate good safety practices at all times, and take initiative to correct safety hazards. Additionally, the incumbent will actively demonstrate and promote the values of accountability, communication, customer commitment, entrepreneurial spirit, integrity, safety and teamwork.Responsibilities include: coordinating the activities of staff members including 3 supervisors and several analysts for the processing of samples; data review; investigations and timely resolution of related excursions; data trending and reporting, and representing the department to regulatory authorities as needed. Responsible for issuing trending reports, test cycle times and metric reports per applicable SOPs and senior management requirements. Ensure up-to-date training for cGMP procedures and safety procedures for the laboratory. Responsible for working with their staff on career continuous improvement development plans. Extensive knowledge of fundamentals of Environmental Monitoring Programs risk assessment and gap analysis, design, applications and management in the Biotechnology/Pharmaceutical fields, Technical and hands on expertise on EM techniques and equipment required. Oversee ELISA, endotoxin, bioburden, particulate, sterility, microbial testing,, EM, critical utility testing, etc. Ensure GMP compliance of all activities performed. Experience with Fill Finish bulk manufacturing operations to provide appropriate microbiology and aseptic control support and technical expertise Thorough knowledge of FDA regulations and international regulatory agencies related to Microbiology issues, Aseptic processing, and biosafety of biologics is essential with ability to represent QC Micro in internal and external audits as required. Develop and execute hiring plans. Recruit, train and supervise staff Coordinate and support validation, engineering and production assignments according to schedule without compromising quality. Oversee and plan QC Micro validation and revalidation of lab equipment and campaigns supported by QC Microbiology (cGMP). Evaluate, propose and implement new technologies as alternatives to optimize efficiencies and effectiveness of the new facilities, processes and programs. Develop and maintain appropriate controls around protocols and procedures, control forms, investigations, laboratory reports and other controlled documents as needed. Maintain positive relationship and network effectively across sites and organizations. Coordinate documentation of laboratory deviations, incidents and investigations.

Job Title: Senior Director, Quality Company: Cubist Location: Lexington, MA Description: Cubist Pharmaceuticals (NASDAQ: CBST) is a biopharmaceutical company focused on the research, development and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. Founded in 1992, Cubist is headquartered in Lexington, MA and has just over 600 employees. Cubist has been ranked among the Top 100 Performing Companies by The Boston Globe for two consecutive years based on financial performance and Forbes ranked Cubist among the Most Trustworthy Mip-Cap Companies. CEO Mike Bonney was also recently awarded the MassBio Leadership Initiative Award for demonstrating active support in the community and a commitment to growth in Massachusetts. Directs the planning and implementation of all quality activities (Quality Assurance and Quality Control) for Cubist. Oversees all quality activities as they relate to both development and commercial products. Provides leadership to entire Quality function (20+ individuals) as well as oversight of contract facilities. Develops and implements strategies, policies and programs in support of quality functions. Key Responsibilities: *Establishing and modifying, as necessary, vision for overall Quality requirements by Cubist for Lexington, partners, contractors and suppliers. *Developing and maintaining quality systems for the Company in compliance with all regulatory agency requirements for the markets served, to oversee: *Production Systems *Material Systems *Laboratory Control Systems *Packaging and Labeling Systems *Facilities and Equipment Systems *Developing and continually improving the strategy for policies and procedures, ensuring compliance with regulatory agency and Cubist partner requirements. *Recruit and train staff to comply with Cubist standards as well as reinforcing training and motivating individuals. *Provide effective leadership in attracting, retaining and developing staff. *Manage internal and external resources for the quality oversight, testing and disposition of API and drug product. *Manage domestic and international facilities which are owned or contracted by Cubist. *Mange GCP, GLP and GMP activities related to clinical and commercial products. *Support Due Diligence and CMC Documentation for submission to worldwide regulatory agencies, with partner input. *Works cross-functionally and representative on cross-functional teams in support of the business. Minimum Basic Qualifications: *Education: A BS or MS in a scientific discipline or equivalent *Minimum of 15 years of quality experience in a biotechnology or pharmaceutical environment Experience Required: *15+ years of experience in a Quality role, including 10+ years in a management position in a pharmaceutical manufacturing company. *Leading and conducting quality audits of API and fill/finish suppliers. *Validation of equipment, processes and systems. *Analytical method development transfer and validation. *Management of Quality Control lab operations and data management. *Conducting regulatory agency inspections. *Experience with GxP's. *Successful track record in managing, leading and developing a team. *Demonstrated success of representing the function on cross-functional, project teams. Desired Competencies and Qualifications: *Drives and supports the success of the group by providing clarity, support and tools needed to excel. *Demonstrates confidence and optimism in ambiguous and/or difficult situations, seeing them as opportunities while energized by solving complex business situations. *Leverages one's understanding and perspective of the external environment to identify possibilities and create opportunities for Cubist. *Flexibly adapting strategies and tactics, based on an external perspective, in order to get essential processes and practices in place or to make improvements. *Maintain a Cubist, rather than a functional, perspective with a collaborative approach, working effectively across the group and organization to achieve goals and drive change. Work Environment: *Interact with all levels of the organization and with current partners. Physical Demands: Office environments with possibility of up to 30% travel, both domestic and international. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Total Rewards: Our outstanding total rewards package includes: competitive base salary; annual incentive plan with cash payouts based on results; company-wide performance based equity program; choice of medical plan; dental, life and disability insurance; employee assistance program; flexible spending accounts; 100% vesting in our 401K plan with a competitive company match; employee stock purchase plan; tuition reimbursement; childcare and eldercare subsidy; 12 paid holidays, 4 of which are floating; 3 weeks vacation; fitness reimbursement program; flexible work schedules; comprehensive reward and recognition program. Application instructions: We encourage you to apply to Cubist by applying directly at: http://hostedjobs.openhire.com/epostings/jobs/submit.cfm?fuseaction=dspjob&jobid=216804&company_id=15975&jobboardid=1710 Submitting a resume online at a job site could cause valuable screening information to be missed. We are an Equal Opportunity Employer. Cubist Pharmaceuticals values its partnerships with 3rd party vendors who work within our established employment processes. All 3rd party resumes must be submitted through the agency portal to the position(s) for which they are authorized to recruit. We will not accept unsolicited resumes from employment agencies for any employment opportunity. All resumes submitted by search firms to any employee at Cubist via-email, the Internet or directly to hiring managers in any form without a signed agency agreement on file and search engagement for that position will be deemed unsolicited in nature, and no fee will be paid in the event the candidate is hired by Cubist as a result of the referral or through other means. Note: Any search agreement entered into and not renewed by Cubist prior to November 2009 are hereinafter void. Employment agencies are an important component to our talent acquisition strategy and we value the partnerships we have built with our preferred vendors. For this reason, we have an established and regularly maintained preferred vendor list. Please note that even preferred vendors must be engaged by Cubist and have agency portal permission granted for the specific position in order for a fee to be paid for any candidate referrals. To Apply for this position, please CLICK HERE

Job Title: Quality Control Manager Company: NPPS Location: Gardner, MA Description: Manufacturing company is interested in hiring an experienced QC/QA manager with experience in flexible packaging, converting, laminating, poly bags/pouches. Compensation packaging will include a negotiable salary, full benefits package, and relocation assistance.

Job Title: Senior Director, FDA Regulatory Compliance, Quality Mgmt IVR EDC CTMS eClinical Remote employees OK Company: Parexel Location: Waltham, MA Description: Sr. Director Quality Management GcP GmP IVR EDC CTMS eClinical FDA regulatory compliance (Sr Dir Ops QM)- remote employees OKProvide management support to Operations Quality Management (i.e., to Managers, Senior Managers, Associate Directors, Directors and senior technical staff) across the eClinical Perceptive Informatics Product Lines, including IVRS, RTSM, Medical Imaging, CTMS, EDC, ePRO and eClinical Integrated Solutions.Key AccountabilitiesProvide management support to the team including the following:Recruit qualified staff and ensure that the resources are sufficient to fulfill the mission of Ops QM.Ensure that staff are appropriately trained when they join the group and thereafter on an ongoing basis.Ensure that performance objectives and a development plan are documented for each employee and that these are reviewed twice annually.Provide coaching, mentoring and constructive feedback to employees.Manage a budget.Maintain a positive, results oriented work environment, building partnerships within the group and across the organization at large, modeling teamwork.Communicate to employees in an open, balanced and objective manner.Empower employees to be the best that they can be.Provide technical oversight and serve as an escalation point where management support and intervention is indicatedOther AccountabilitiesWork closely and collaboratively with other Management within and outside of Ops QM.Build and maintain successful relationships with clients.Actively participate in relevant external meetings and/or associations.Identify process improvement opportunities and champion their implementation.Maintain an understanding of PAREXEL standard operating procedures and of relevant regulations and guidelines.Perform other quality related tasks as assigned.Keywords: quality management system, qms, gcp, gmp, eClinical, medical imaging, IVRS, EDC, CTMS, ePRO, 21 cfr part 11, fda, regulatory complianceGROWTH:While most companies were busy downsizing, PAREXEL added over 2100 employees in 2009 alone!!PROMOTION:In 2009, more than 1200 PAREXEL employees received career promotions!!EXPERTISE:PAREXEL's experts, who have experience across a broad range of therapeutic areas, have supported nearly all of the top 50 best selling drugs that are on the market today.AWARDS:Scrip Award for Best CRO 2008, BioSingapore Award for Best Performing CRO 2009, Good Clinical Practice Journal, Most Innovative Patient Recruitment Strategy 2008,Globe 100 - Top 10 Best-Performing Massachusetts-Based Public Company 2009 (including Top Employer Ranking by number of world wide employees)

Job Title: Associate Director, Quality Control Company: Shire Location: Lexington, MA Description: Oversees development, validation, implementation, and maintenance of QC functional group standards, instruments, methods, reagents, critical components, cGMP documents and sample handling, and electronic systems to execute QC functional group responsibilities within specifications or procedures or policies, and maintain lab's cGMP readiness at all times globally (Outside MA, USA). Oversees management of contract labs globally, which includes import testing labs. Responsibilities: Responsible for Shire HGT contract labs and Shire owned labs globally (Outside MA, USA) Responsible for timely reporting of accurate data to customers and management, and provide accurate and timely updates of functional group activities to QC management with a focus on cycle times, cost management, staff productivity and efficiency, and identification and resolving obstacles to maintain a highly effective and productive functional group. Interact regularly with customers to meet the needs and communicate activities and issues to line Management on a regular and timely manner to meet the department needs. Support to prepare and track budget of the group activities including staff overtime and temporary contractor budget within the scope of accountability and responsibility. Prepare capital appropriation requests for new and/or replacement equipment as necessary and bring all the equipment into use within an agreed upon time frame based on operational needs and to maximize the return on the investment. Responsible for timely hiring, training and development of qualified staff to ensure effective testing, execution of roles and responsibilities, GMP compliance, and attainment of operational and development goals. Maintain daily staffing requirements to meet business needs. Responsible for continuous improvement on an ongoing basis to proactively mitigate current and future risks to maintain an effective lab operation to support business needs. Responsible for short and long term goals of quality control laboratory efforts in support of IND, NDA, BLA, clinical and commercial products supply and program driven milestones. Provides advice, guidance and assistance in a broad aspect for the functional group and the department. Provide Program and Regulatory support on an on going basis, which includes IND amendments, BLA filings, and FUM's Oversight of validation and tech transfer of analytical methods Effective interface with Development, Regulatory, CMC Teams, Quality Groups, Manufacturing, and Manufacturing Technical Services groups Participate to develop continuous improvement plans, including processes and guidelines and processes for efficient and compliant systems and operations Oversee GMP facilities from Utilities and in-process controls Support contract labs audits Support agency inspections of Shire owned labs outside MA, USA Promote and exhibit Shire Values