Director, Quality – Contamination Control, Microbial Excellence

This is a fully remote position, open to applicants in Ireland.

📋 Description

• Assist site-based CCME colleagues in the development, execution, and maintenance of site contamination control strategies, ensuring alignment with global quality protocols and EU GMP Annex 1, FDA 21 CFR, ISO, and PIC/S standards.

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

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

• Provide above-site support and guidance to PSG sites regarding complex deviations or laboratory investigations related to Microbiology, Contamination Control, and Sterility Assurance.

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

• Deliver above-site support and guidance to PSG sites for intricate risk assessments related to Microbiology, Contamination Control, and Sterility Assurance.

• Offer guidance during facility and process design, 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 that affect CCME, including the appropriate 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.

• 8–10 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.

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

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

• Proficient communicator, capable of influencing and collaborating with cross-functional teams.

• Previous experience with regulatory inspections and audit defense.

• Experience with CCS implementation is preferred.

🏝️ Benefits

• Health insurance

• Professional development