Director Quality Assurance

The Quality Assurance Director will provide compliance leadership and direction to our Company and contract manufacturing operation (CMO) sites that manufacture active pharmaceutical ingredients (API), biologics, vaccine drug substances and finished products. As Director, you will support Quality audits and health authority inspections and ensure any resulting corrective and preventative actions (CAPA) are effectively implemented.Primary ActivitiesServe as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturingPartner with our Company and CMO management to identify appropriate CAPA to address findings identified during audits and inspections. Monitor CAPA status and ensure CAPA are implemented in accordance with commitments. Perform independent verification of CAPA implementation and effectiveness to ensure no recurrence of findingsGather regulatory intelligence and partner with our Company and CMO management to prepare sites for audits and inspections. Assists sites during audits and inspections to ensure successful outcomesMonitor and analyze the outcomes of audits and inspections to identify, investigate, and resolve trends. Report results to Divisional and Regional Quality/Management councilsProvide guidance and consultation services for regulatory reporting (e.g., BPDR, DPR)Author and/or review global standards and procedures related to biologics, vaccines, and finished product ensuring compliance with regulatory requirementsActively participate in industry organizations such as PDA, PQRI, PhRMA, ISPE, etc.Education and Required Experience:Bachelors degree in Life Sciences, Chemistry, Engineering or related relevant discipline and 10+ years of demonstrated experience within Quality compliance within large molecule manufacturing industryExpert knowledge of GMP requirements for multiple regulatory agenciesExpert knowledge of large molecule manufacturing processes (for biologics and/or vaccines) and sterility assurance requirementsAbility to accurately interpret and apply regulatory expectations for a robust and compliant QMSExperience in health authority inspectionsRequired Skills:Drive Results - set clear performance standards, overcome obstacles; accountable for actions and achieve resultsMake Rapid, Disciplined Decisions - demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisionsAct with Courage and Candor - ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriateFoster Collaboration - ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignmentMake Rapid, Disciplined Decisions - demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisionsAct with Courage and Candor - ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriatePreferred Skills/Experience:Experience working for a health authority as an inspector, investigator, compliance officer, reviewer, or assessorExperience creating or assessing remediation plans#EBRGCurrent Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA SupplementWe are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsU.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".The salary range for this role is$169,700.00 - $267,200.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring OrdinanceSearch Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:50%Flexible Work Arrangements:RemoteShift:1st - DayValid Driving License:YesHazardous Material(s):N/ARequired Skills:Biological Sciences, Biologics, Biopharmaceutics, Corrective and Preventive Action (CAPA), Detail-Oriented, Driving Continuous Improvement, GMP Compliance, Manufacturing, Pharmaceutical Quality Control (QC), Preventive Action, Quality Assurance (QA), Quality Assurance Auditing, Quality Assurance Inspection, Quality Control Inspection, Quality Management, Quality Management Systems (QMS), Quality Metrics, Regulatory Compliance, Regulatory Inspections, Vaccine ManufacturingPreferred Skills:Quality Control Reviews, Remediation PlansJob Posting End Date:07/27/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R355668PDN-9f68b9d0-5678-48d9-8dfc-7271a30b1410