MSD
Associate Director, Quality Assurance — MSD
Location: West Point, PA | Salary Range: $142,400.00 - $224,100.00 (as posted 04/2024)
Overview 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.
Key Responsibilities
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).
Education & Minimum Qualifications
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.
Preferred Experience & Skills
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.
Required Technical Skills
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
Compensation & Benefits
Salary Range: $142,400.00 – $224,100.00
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.
Equal Employment Opportunity 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.
Application Information Apply through https://jobs.merck.com/us/en (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.
Job Posting End Date 01/19/2026
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Overview 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.
Key Responsibilities
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).
Education & Minimum Qualifications
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.
Preferred Experience & Skills
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.
Required Technical Skills
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
Compensation & Benefits
Salary Range: $142,400.00 – $224,100.00
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.
Equal Employment Opportunity 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.
Application Information Apply through https://jobs.merck.com/us/en (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.
Job Posting End Date 01/19/2026
#J-18808-Ljbffr