Associate Director Quality Assurance

Overview

Join to apply for the Associate Director Quality Assurance role at MSD Ireland
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The incumbent will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group that has global responsibility for microbial control and sterility assurance related topics.

• 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)

• 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

• 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

• Adaptability
• Biopharmaceutical Industry
• Biopharmaceuticals
• Biopharmaceutics
• Change Management
• Communication
• Contamination Control
• Cross-Cultural Awareness
• Cross-Functional Teamwork
• Environmental Monitoring
• GMP Training
• Inspection Readiness
• Leadership
• Manufacturing Quality Control
• Microbiology
• Quality Management Standards
• Quality Systems Compliance
• Regulatory Compliance
• Regulatory Inspections
• Risk Management
• Sterility Assurance
• Technical Problem-Solving

• Current Employees apply HERE
• Current Contingent Workers apply HERE

• US And Puerto Rico Residents Only
• Our company is committed to inclusion and providing accommodations in the hiring process;  if you need an accommodation during the application or hiring process.
• Salary range: $ - $
• Hybrid work model in the U.S. (three days on-site per week, Monday-Thursday; Friday remote unless business critical tasks require on-site). This may not apply to all roles.
• Travel Requirements: 25%
• Job Posting End Date: 01/19/2026

Important:
Equal Employment Opportunity information is included in the original description and has been preserved here where applicable.