Director, Microbiological Quality and Sterility Assurance (MQSA)

Director, Microbiological Quality and Sterility Assurance

Job Description

We aspire to be the premier research-intensive biopharmaceutical company. At the forefront of research, we deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

The Director, Microbiological Quality and Sterility Assurance (MQSA) provides global leadership for microbiology-related topics across sterile, non-sterile, biologic, and vaccine manufacturing, as well as associated laboratories. This role sets and maintains quality standards and policies to ensure cGMP compliance, partners with sites across the network as a subject matter expert, and leads cross-site initiatives to drive consistency and continuous improvement.

Join our team and use the power of leading-edge science to save and improve lives around the world.

Responsibilities

• Provide leadership and direction for filtration related topics in sterile, non-sterile, biologic, and vaccine manufacturing.
• Lead the development, deployment, and maintenance of multiple divisional quality standards and policies to ensure compliance with cGMPs.
• Work directly with multiple sites providing SME support to our Manufacturing Division network.
• Lead divisional projects across internal and external sites.
• Identify regulatory requirements, cGMP expectations, and industry trends.
• Develop, author, and maintain divisional quality standards in alignment with regulatory requirements, cGMP expectations, and industry trends.
• Deploy and ensure consistency across our Manufacturing Division sites in meeting divisional standards.
• Define and track quality metrics to transform performance at our Manufacturing Division network sites.
• Provide SME guidance and input on sterility assurance, microbial control, sterile and low bioburden manufacturing, and microbiological control/testing.
• Organize and facilitate compliance-related communities of practice.
• Represent our company in external forums, conferences, and working groups such as ISPE, PDA, PhRMA, BPOG, or USP.
• Understand compliance gaps and quality improvement goals for microbiology and sterility assurance topics.
• Work with sites and regional Quality organizations to ensure consistency and alignment to microbiology contamination and control topics.
• Act as Quality reviewer for new technologies, helping to define strategy and deployment.
• Provide SME support to sites related to regulatory inspections, development of responses to inspection observations, significant microbiological investigations, and guidance regarding corrective actions.
• Author and/or review technical reports/position papers and proactively lead divisional initiatives in designated areas of expertise.
• Lead global cross-functional teams to drive compliance/technical initiatives to strengthen Network compliance posture.

This position can sit out of any US eligible work sites and some EU eligible work sites.

Qualifications

Required

• Bachelor of Science (B.S.), in Science or Engineering such as Microbiology, Biology, Virology, Biochemical Engineering, Pharmacy, or related science discipline with a minimum of Ten (10) years required experience in pharmaceutical, biopharmaceutical, vaccine, or medical device industry; OR M.S. with eight (8) years of required experience OR Ph. D with five (5) years of required experience
• Expert knowledge in filtration, including validation of sterile filtration processes.
• Expert knowledge of topics related to sterile, non-sterile, or biologic processing and/or microbiology methods including contamination control.
• Experience in transforming GMP compliance and highly experienced in regulatory inspections and responses.
• Excellent spoken and written English.
• Demonstrates strong leadership capabilities and ability to work cross-functionally to develop solutions and champion a position.
• Demonstrated ability to effectively work hands-on with shop floor personnel.
• Ability to upskill individuals on topics such as microbiological methods, requirements/regulations, microbiological contamination control.
• Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies such as US FDA, EMEA, TGA, ANVISA, and PMDA.
• Knowledge of USP and EU compendia and ISO industry standards.
• Quality Risk Management knowledge and experience.

Preferred

• Advanced Degree is preferred

Required Skills:

Biological Sciences, Biological Sciences, Biomanufacturing, Biopharmaceutical Industry, Corrective Action Management, Cross-Cultural Awareness, Customer-Focused, Data Integrity, Detail-Oriented, Driving Continuous Improvement, Ethical Compliance, GMP Compliance, Immunochemistry, Innovation, Mentoring Staff, Microbiological Analysis, Microbiological Methods, Microbiology, Pharmaceutical Quality Control (QC), QA Metrics, Quality Management Systems (QMS), Quality Methods, Quality Metrics, Quality Risk Management, Quality Tools {+ 6 more}

Preferred Skills:

Salary range for this role is $173,200.00 - $272,600.00

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, 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

You 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 Ordinance

Los 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 Ordinance

Search Firm Representatives Please Read Carefully Merck & 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: Regular

Relocation: No

VISA Sponsorship: No

Travel Requirements: 50%

Flexible Work Arrangements: Hybrid

Shift: 1st - Day

Valid Driving License: No

Hazardous Material(s): n/a

Job Posting End Date: 07/11/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the 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: R403153