Associate Director Quality Assurance

Job Description

The incumbent will be part of the Microbiological Quality & Sterility Assurance organization, a Quality Assurance group with global responsibility for microbial control and sterility assurance topics.

In the Associate Director role, they will provide subject matter expertise for microbiology/virology related topics in biologic, vaccine sterile, non‑sterile manufacturing, and/or testing laboratories.

Roles include developing, deploying, and maintaining divisional quality standards and policies to ensure compliance with cGMPs, supporting divisional projects, strategy development for compliance, and regulatory inspection support.

• Develop, author and maintain divisional quality standards aligned with regulatory requirements and industry trends.
• Assist manufacturing sites and project teams with strategy, regulatory interactions, inspection responses, QMS compliance, microbiological investigations, and guidance on corrective actions.
• Champion company initiatives to improve compliance and consistency across practices.
• Participate in external industry and regulatory forums to stay abreast of trends.
• Maintain industry‑leading expertise in the designated subject area(s).

• B.S., M.S. or Ph.D. (or equivalent) preferably in Science or Engineering such as Microbiology, Biology, Biochemical Engineering, Pharmacy, or related disciplines.

• Minimum 8 years in the pharmaceutical, biopharmaceutical, vaccine, or medical device industry.
• Technical problem‑solving abilities.
• Strong communication, planning, collaboration, negotiation, and technical writing skills.
• Knowledge of international GMPs, quality management requirements of agencies such as US FDA, EMEA, TGA, PMDA, USP, EU compendia, ISO standards.
• Ability to travel up to 20 % of the time to manufacturing sites in USA, Europe, Latin America and/or Asia.

• Advanced subject expertise in 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.
• Experience in regulatory inspections and response preparation.
• Leadership capabilities and ability to work cross‑functionally to develop solutions.
• Hands‑on working with shop floor personnel and ability to upskill individuals on relevant topics.
• Quality risk management knowledge and experience.

Adaptability, biopharmaceutical industry knowledge, 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.

Current Employees apply HERE. Current Contingent Workers apply HERE.

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. We comply with affirmative action requirements for protected veterans and individuals with disabilities.

Salary range: $ – $.

Eligible for annual bonus and long‑term incentive, if applicable.

Benefits include medical, dental, vision, retirement (401(k)), paid holidays, vacation, compassionate and sick days.

Apply through  (or Workday Jobs Hub for current employees). Deadline stated on posting.