Sterility Assurance Manager EMEA

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. Since 1931, we have been redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Baxter colleagues are united by our Mission to Save and Sustain Lives, driven by a culture of courage, trust, and collaboration.

We are seeking 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, ensuring that contamination control, environmental monitoring, and aseptic practices are standardized and maintained according to cGMP regulations, global regulatory standards, and Baxter's global strategy across all EMEA sites.

Key Responsibilities

• Develop and implement sterility assurance strategies across EMEA compounding sites
• Act as an SME on sterility assurance in the EMEA Compounding team and serve as the primary point of contact for regulatory agencies during on‑site inspections and 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
• 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
• 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
• 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

• Microbiology or Biotechnology degree with experience in aseptic techniques
• Validated experience in sterility assurance or aseptic manufacturing within the pharmaceutical or biotechnology industry, preferably 5 years 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
• Operational experience in aseptic manufacturing and lean manufacturing practices is desirable
• Proficiency in English; knowledge of French and Italian is desirable

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability status or any other legally protected characteristic.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees, recruiters, or other agents. To learn how you can protect yourself, review our Recruitment Fraud Notice.