Associate Director, Quality Assurance

Associate Director, Microbiological Quality & Sterility AssuranceThe 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.In the Associate Director role, the incumbent will provide subject matter expertise for microbiology and/or virology related topics in biologic, vaccine sterile, non-sterile manufacturing and/or testing laboratories for assigned topics. Supports the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our company is compliant to cGMPs for these topics. Supports divisional projects across internal and external sites. Supports development of strategy to drive compliance and continuous improvement in the network. Delivers support for regulatory inspections and responses.The incumbent must be experienced in one or more subject areas including low bioburden operations, sterile/aseptic manufacturing and facility design, microbiological and/or adventitious agent contamination control, sterile/aseptic manufacturing and facility design, environmental monitoring, cleaning and disinfection and critical utilities. This role will require collaboration and global coordination of work across Quality and above site groups. Responsibilities contain Quality, regulatory, and business elements.The incumbent will be responsible for:Developing, authoring, and maintaining the divisional quality standards in alignment with regulatory requirements, cGMP expectations, and industry trendsAssisting 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 actionsChampioning company initiatives and projects to improve compliance and consistency in practices across the company in the designated area of expertiseParticipating in external industry and regulatory forums to stay abreast of industry trendsEstablishing/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 abilitiesStrong communications, planning and collaboration/negotiation skillsTechnical writing proficiencyKnowledge 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 standardsAbility and willingness to travel to the manufacturing sites in USA, Europe, Latin America and /or Asia for up to 20% of the timePreferred 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 methodsHighly 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 controlQuality 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, Good Distribution Practice (GDP), Inspection Readiness, Leadership, Manufacturing Quality Control, Microbiology, Quality Management Standards, Quality Systems Compliance, Regulatory Compliance, Regulatory Inspections, Risk Management, Sterility Assurance, Technical Problem-SolvingPreferred Skills:The salary range for this role is $142,400.00 - $224,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.You can apply for this role throughhttps://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation: DomesticVISA Sponsorship: NoTravel Requirements: 25%Flexible Work Arrangements: HybridShift: 1st - DayValid Driving License: NoHazardous Material(s): n/aJob Posting End Date: 01/19/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID: R377562