Overview
Join to apply for the Associate Director Quality Assurance role at MSD Ireland .
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.
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)
Education Minimum Requirement
- 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
Required Experience And Skills
- 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 Experience And Skills
- 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
Required Skills
- 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
Preferred Skills
- Current Employees apply HERE
- Current Contingent Workers apply HERE
Hiring Details
- US And Puerto Rico Residents Only
- Our company is committed to inclusion and providing accommodations in the hiring process; click here if you need an accommodation during the application or hiring process.
- Salary range: $142,400.00 - $224,100.00
- 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.
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