Overview 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 Activities Serve as a subject matter expert for current good manufacturing practice (CGMP) requirements for vaccine and large molecule manufacturing Partner 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 findings Gather 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 outcomes Monitor and analyze the outcomes of audits and inspections to identify, investigate, and resolve trends. Report results to Divisional and Regional Quality/Management councils Provide 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 requirements Actively 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 industry Expert knowledge of GMP requirements for multiple regulatory agencies Expert knowledge of large molecule manufacturing processes (for biologics and/or vaccines) and sterility assurance requirements Ability to accurately interpret and apply regulatory expectations for a robust and compliant QMS Experience in health authority inspections Required Skills Drive Results – set clear performance standards, overcome obstacles; accountable for actions and achieve results Make Rapid, Disciplined Decisions – demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions Act with Courage and Candor – ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate Foster Collaboration – ability to influence, facilitate groups with diverse perspectives, bring teams to consensus/alignment Make Rapid, Disciplined Decisions – demonstrates good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions Act with Courage and Candor – ability and willingness to advocate for compliance position using objective evidence, escalates issues and decisions, as appropriate Preferred Skills/Experience Experience working for a health authority as an inspector, investigator, compliance officer, reviewer, or assessor Experience creating or assessing remediation plans US 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. We 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. U.S. Hybrid Work Model: Effective 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, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to field-based, facility-based, manufacturing-based, or research-based positions, or roles designated remote. The salary range for this role is $169,700.00 - $267,200.00. This 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 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 https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through the Merck careers site or Workday Jobs Hub if you are a current employee. The application deadline for this position is stated on this posting. Travel Requirements: 50% Shift: 1st - Day Valid Driving License: Yes Hazardous Material(s): N/A Required 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 Manufacturing Preferred Skills: Quality Control Reviews, Remediation Plans Job Posting End Date: 09/15/2025 Requisition ID: R355668

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