Job Description
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.
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 Manufacturing Division 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 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. #VetJobs #EBRG's
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
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US And Puerto Rico Residents Only
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
Requirements
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://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
Regular
Relocation:
Domestic
VISA Sponsorship
No
Travel Requirements
25%
Flexible Work Arrangements
Hybrid
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
N/A
Job 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:R377567
