MSD Ireland
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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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.
#J-18808-Ljbffr