Sterility Assurance Manager EMEA Compounding

Sterility Assurance Manager EMEA Compounding

Baxter International

Lesquin, France

SUMMARY

We are looking for a Sterility Assurance Manager to lead the development and implementation of sterility assurance strategies across aseptic compounding facilities in the EMEA region. As the regional Subject Matter Expert (SME) in microbiology and sterility assurance, you will drive continuous improvement and innovation in sterility assurance programs. Your role involves ensuring that contamination control, environmental monitoring, and aseptic practices are standardized and maintained in line with cGMP regulations, global regulatory standards, and Baxter's global strategy across all EMEA sites.

KEY RESPONSIBILITIES

Sterility Assurance Leadership

• Develop and implement sterility assurance strategies across EMEA compounding sites;
• Acting as a SME on sterility assurance in the EMEA Compounding team and as a primary Point-of-Contact for the relevant Regulatory Agencies during the on-site inspections and the relevant follow-up (e.g., MHRA, HPRA, ANSM, AIFA);
• Lead the EMEA Sterility Assurance network and collaborate with the Global Sterility Assurance Council;
• Maintain professional standards and continuously improve expertise;
• Promote and uphold the Quality Policy and Business Objectives by embedding quality in all activities.

Environmental Monitoring & Contamination Control

• Ensure effective deployment of environmental monitoring programs in compliance with GMP and global standards;
• Analyze environmental monitoring data and contamination events to identify risks and improvement opportunities.

Continuous Improvement & Innovation

• Identify and implement process improvements to strengthen the Sterility Assurance program while maintaining compliance;
• Encourage a culture of constant improvement to mitigate contamination risks and advance strategic objectives;
• Support standardization of sterility assurance practices across the Compounding organization;
• Evaluate and implement new technologies for microbiological testing and environmental control (e.g., rapid microbial methods, automation);
• Collaborate with engineering and manufacturing teams to optimize aseptic processes and facility design.

Training & Compliance

• Ensure adequacy of training materials and periodic retraining for operational and quality staff;
• Provide mentoring on sterility assurance problem-solving across functions and sites;
• Review and approve sterility assurance-related Change Controls and documentation (e.g. risk assessments, regional procedures…);
• Ensure compliance with Annex 1, ICH, MHRA Special Guidance, EP, BP, and other relevant regulatory guidelines.

QUALIFICATIONS

• A Microbiology, Biotechnology degree with experience of aseptic techniques;
• Validated experience in sterility assurance or aseptic manufacturing within the pharmaceutical or biotechnology industry - preferably have 5 years’ experience of microbiology experience in an aseptic facility;
• Proven leadership experience in multi-site or regional roles;
• Proficient knowledge of GMP, aseptic methods, and contamination management techniques;
• Experience with regulatory inspections in the EU;
• Preferably Operational experience in aseptic manufacturing and lean manufacturing practices;
• Proficiency in English; knowledge of French and Italian is desirable.