Sterility Assurance Sr Mgr EMEA Compounding

Baxter International Inc.; Toscana; In loco; EUR 80.000 - 100.000; Tempo pieno

Descrizione del lavoro

A leading global healthcare company in Italy is seeking a Sterility Assurance Sr Manager to lead the development and implementation of aseptic compounding strategies. The ideal candidate will have extensive experience in microbiology, a strong leadership background, and a deep understanding of regulatory compliance in the pharmaceutical industry. This full-time role emphasizes innovation and quality assurance across multiple sites in the EMEA region.

Competenze

• 5+ years of experience in microbiology in an aseptic facility.
• Experience in a leadership role in a multi-site environment.
• Validated experience in sterility assurance within the pharmaceutical industry.

Mansioni

• Develop and implement sterility assurance strategies across EMEA sites.
• Lead the EMEA Sterility Assurance network and collaborate with relevant agencies.
• Ensure compliance with GMP and global standards in environmental monitoring.

Conoscenze

Microbiology expertise

Leadership experience

GMP knowledge

Aseptic techniques

Contamination management

Regulatory inspection experience

English proficiency

Knowledge of French and Italian

Formazione

Degree in Microbiology or Biotechnology

Descrizione del lavoro

Sterility Assurance Sr Mgr EMEA Compounding

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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.

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

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/handicap 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, 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.

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Seniority level

Director

Employment type

Full-time

Job function

Accounting/Auditing and Finance

Industries

Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health Care