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MSD · 1 week ago

Associate Director, Quality Assurance

West Point, PA

Full-time

Hybrid

Lead/Staff, Director/Executive

$142K/yr - $224K/yr

8+ years exp

MSD is part of the Microbiological Quality & Sterility Assurance organization, which has global responsibility for microbial control and sterility assurance. The Associate Director will provide subject matter expertise in microbiology and virology for biologic and vaccine manufacturing and testing laboratories, ensuring compliance with cGMPs and supporting regulatory inspections.

BiopharmaBiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Developing, authoring, and maintaining the divisional quality standards in alignment with regulatory requirements, cGMP expectations, and industry trends

Assisting manufacturing sites and project teams with project strategy, regulatory interactions, development of responses to inspection observations, QMS compliance, significant microbiological investigations, and guidance regarding corrective actions

Championing company initiatives and projects to improve compliance and consistency in practices across the company in the designated area of expertise

Participating in external industry and regulatory forums to stay abreast of industry trends

Establishing/maintaining industry-leading expertise in the designated subject area(s)

Qualification

MicrobiologyRegulatory ComplianceQuality Management StandardsTechnical Problem-SolvingSterility AssuranceEnvironmental MonitoringChange ManagementLeadershipCommunicationCollaboration

Required

B.S., M.S. or Ph.D (equivalent degrees acceptable) preferably in Science or Engineering such as 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 communications, planning and collaboration/negotiation skills

Technical writing proficiency

Knowledge of international GMPs and Quality Management requirements of various regulatory agencies (e.g. US FDA, EMEA, TGA, PMDA, etc.) as well as USP compendia, EU compendia and ISO industry standards

Ability and willingness to travel to the manufacturing sites in USA, Europe, Latin America and /or Asia for up to 20% of the time

Preferred

Advanced subject expertise in one or more of the following areas 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

Highly experienced in regulatory inspections and response preparation

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

Quality Risk Management knowledge and experience