Director Quality Assurance

Director Quality Assurance at Merck & Co., Inc. / MSD

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:

• Bachelor's 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

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.

About Us

We are one company, but we operate under two different corporate brand names. We are known as Merck & Co., Inc., Rahway, NJ, USA in the United States, Canada & Puerto Rico. We are known as MSD everywhere else.