Director, Quality – Contamination Control, Microbial Excellence

This is a fully remote position, open to applicants in New Jersey, +4 more states.

📋 Description

• Assist site-based CCME colleagues in the development, execution, and maintenance of strategies for contamination control, adhering to contamination control risk assessments that align with global quality standards and EU GMP Annex 1, FDA 21 CFR, ISO, and PIC/S.

• Offer subject matter expertise (SME) in microbiology, microbiological techniques, contamination control, aseptic processing, Environmental Monitoring, cleanroom design, cleaning, disinfection, and other pertinent areas required by site CCME teams and corporate quality management.

• Aid in the global analysis of EM trends from the PSG network and collaborate with site teams to address adverse trends while ensuring environmental control in all cleanrooms.

• Provide off-site support and guidance to PSG sites for complex deviations or laboratory investigations concerning Microbiology, Contamination Control, and Sterility Assurance.

• When applicable, assist in defining CAPA plans, preventive measures, and initiatives for continuous improvement.

• Offer off-site support and direction to PSG sites for intricate risk assessments related to Microbiology, Contamination Control, and Sterility Assurance.

• Deliver guidance during the design of facilities and processes, including contamination controls led by design and the flow of materials, personnel, and waste.

• Contribute SME input into the qualification of manufacturing equipment and cleanrooms affecting CCME, ensuring the correct selection and validation of sterilization processes (e.g., autoclaves, SIP, filter integrity testing).

• Ensure Inspection Readiness.

• Promote digitalization and innovation across PSG sites.

⛳️ Requirements

• Bachelor’s or advanced degree in Microbiology, Pharmaceutical Sciences, Biotech, or a related discipline.

• 5–10 years of experience in supporting sterile/low bioburden pharmaceutical manufacturing and/or microbiology roles.

• Strong comprehension of aseptic manufacturing, cleanroom classification, disinfection, and contamination control.

• Extensive knowledge of GMP, Annex 1 (2022 revision), and FDA aseptic guidance.

• Familiarity with barrier technologies (RABS, isolators) and their implementation.

• Excellent communication skills, capable of influencing and collaborating with cross-functional teams.

• Previous experience with regulatory inspections and audit defense.

• Experience with CCS implementation is preferred.

🏝️ Benefits

• A selection of national medical and dental plans, along with a national vision plan, including health incentive programs.

• Employee assistance and family support programs, which feature commuter benefits and tuition reimbursement.

• A minimum of 120 hours of paid time off (PTO), 10 paid holidays each year, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, as well as short- and long-term disability in accordance with company policy.

• Retirement and savings options, including our competitive 401(k) U.S. retirement savings plan.

• The Employees’ Stock Purchase Plan (ESPP) provides eligible colleagues the chance to buy company stock at a discounted rate.