Sterility Assurance Manager EMEA

This is where your work makes a difference.At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.Here, you will find more than just a job—you will find purpose and pride.SummaryWe 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 ResponsibilitiesSterility Assurance LeadershipDevelop and implement sterility assurance strategies across EMEA compounding sitesActing 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 CouncilMaintain professional standards and continuously improve expertisePromote and uphold the Quality Policy and Business Objectives by embedding quality in all activitiesEnvironmental Monitoring & Contamination ControlEnsure effective deployment of environmental monitoring programs in compliance with GMP and global standardsAnalyze environmental monitoring data and contamination events to identify risks and improvement opportunitiesContinuous Improvement & InnovationIdentify and implement process improvements to strengthen the Sterility Assurance program while maintaining complianceEncourage a culture of constant improvement to mitigate contamination risks and advance strategic objectivesSupport standardization of sterility assurance practices across the Compounding organizationEvaluate 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 designTraining & ComplianceEnsure adequacy of training materials and periodic retraining for operational and quality staffProvide mentoring on sterility assurance problem-solving across functions and sitesReview 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 guidelinesQualificationsA 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 rolesProficient knowledge of GMP, aseptic methods, and contamination management techniquesExperience with regulatory inspections in the EUPreferably Operational experience in aseptic manufacturing and lean manufacturing practicesProficiency in English; knowledge of French and Italian is desirableEqual Employment OpportunityBaxter 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/handicap status or any other legally protected characteristic.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.Recruitment Fraud NoticeBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.#J-18808-Ljbffr