Sterility Assurance Manager – EMEA
Baxter International Inc.
full-time
Posted on:
Location Type: Office
Location: Montpellier • 🇫🇷 France
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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
- Ensure effective deployment of environmental monitoring programs in compliance with GMP and global standards
- Identify and implement process improvements to strengthen the Sterility Assurance program while maintaining compliance
- Ensure adequacy of training materials and periodic retraining for operational and quality staff
Requirements
- 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
Benefits
- Reasonable Accommodations
- Professional development opportunities
- Health insurance
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
microbiologybiotechnologyaseptic techniquessterility assuranceGMPcontamination managementlean manufacturingenvironmental monitoringprocess improvementsregulatory inspections
Soft skills
leadershipcollaborationcommunicationtrainingorganizational skills