APHL Annual Report
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. They will support the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our company is compliant with cGMPs for these topics, support divisional projects across internal and external sites, develop strategy to drive compliance and continuous improvement in the network, and deliver 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, environmental monitoring, cleaning and disinfection and critical utilities. The role will require collaboration and global coordination of work across Quality and above site groups. Responsibilities contain Quality, regulatory, and business elements.
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: 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
U.S. Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid work model 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".
Salary Range $142,400.00 – $224,100.00
Benefits 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.
Equal Employment Opportunity 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
Learn more about your rights, including under California, Colorado and other U.S. State Acts
Location‑Specific Considerations 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.
Job Posting End Date 01/19/2026 (The posting is effective until 11:59:59PM the day before the listed job posting end date.)
Requisition ID R377562
#J-18808-Ljbffr
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. They will support the development, deployment and maintenance of multiple divisional quality standards and divisional policies to ensure our company is compliant with cGMPs for these topics, support divisional projects across internal and external sites, develop strategy to drive compliance and continuous improvement in the network, and deliver 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, environmental monitoring, cleaning and disinfection and critical utilities. The role will require collaboration and global coordination of work across Quality and above site groups. Responsibilities contain Quality, regulatory, and business elements.
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: 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
U.S. Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid work model 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".
Salary Range $142,400.00 – $224,100.00
Benefits 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.
Equal Employment Opportunity 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
Learn more about your rights, including under California, Colorado and other U.S. State Acts
Location‑Specific Considerations 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.
Job Posting End Date 01/19/2026 (The posting is effective until 11:59:59PM the day before the listed job posting end date.)
Requisition ID R377562
#J-18808-Ljbffr