Director, Microbiological Quality and Sterility Assurance (MQSA)

MSD•Durham, NC

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

Advanced Degree is preferred

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.