Associate Director, Quality Assurance

Associate Director, Quality Assurance — MSD

Location:

West Point, PA | Salary Range: $ - $ (as posted 04/2024)

The Associate Director will belong to the Microbiological Quality & Sterility Assurance organization, responsible for microbial control and sterility assurance across the company. The role provides expertise in microbiology/virology for biologic, vaccine sterile, and non-sterile manufacturing and testing laboratories.

• Develop, author, and maintain divisional quality standards in alignment with regulatory requirements, cGMP expectations, and industry trends.
• Assist manufacturing sites and project teams with strategy, regulatory interactions, responses to inspection observations, QMS compliance, microbiological investigations, and corrective action guidance.
• Champion company initiatives to improve compliance and consistency across the organization in the designated area of expertise.
• Participate in external industry and regulatory forums to stay abreast of industry trends.
• Maintain industry-leading expertise in the relevant subject area(s).

• B.S., M.S. or Ph.D. (equivalents acceptable) preferably in Microbiology, Biology, Biochemical Engineering, Pharmacy, or related science discipline.
• Minimum 8 years in pharmaceutical, biopharmaceutical, vaccine or medical device industry.
• Technical problem‑solving abilities.
• Strong communication, planning, collaboration, and negotiation skills.
• Technical writing proficiency.
• Knowledge of international GMPs and Quality Management requirements of agencies such as US FDA, EMEA, TGA, PMDA, USP compendia, EU compendia, ISO standards.
• Ability and willingness to travel to manufacturing sites in USA, Europe, Latin America, and/or Asia for up to 20% of the time.

• Advanced subject expertise in low bioburden operations, microbiological contamination control, virology, adventitious agent contamination control, sterile/aseptic manufacturing and facility design, environmental monitoring, cleaning and disinfection, critical utilities, microbiology methods.
• Experience with regulatory inspections and response preparation.
• Leadership capabilities; cross‑functional collaboration.
• Hands‑on experience working with shop floor personnel; ability to upskill teams.
• Knowledge of Quality Risk Management.

• Adaptability
• Biopharmaceutical Industry knowledge
• Change Management
• Communication
• Contamination Control
• Cross‑Cultural Awareness
• Cross‑Functional Teamwork
• Environmental Monitoring
• GMP Training
• Good Distribution Practice (GDP)
• Inspection Readiness
• Leadership
• Manufacturing Quality Control
• Microbiology
• Quality Management Standards
• Quality Systems Compliance
• Regulatory Compliance
• Risk Management
• Sterility Assurance
• Technical Problem‑Solving

• Salary Range: $ – $
• Eligibility for annual bonus and long‑term incentive when applicable.
• Comprehensive benefits package: medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.
• Hybrid work model: 3 days onsite per week (Mon‑Thu), remote one day (Fri); some roles may be remote.

MSD is an Equal Employment Opportunity Employer. We provide equal opportunities for 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 legally protected characteristics. For more information about personal rights under U.S. Equal Opportunity Employment laws, visit the U.S. Equal Employment Opportunity Commission website.

Apply through  (or via the Workday Jobs Hub for current employees). Deadline for application is stated on the posting. Only US, Puerto Rico, San Francisco, and Los Angeles residents can apply as required.

01/19/2026