Sterility Assurance Sr Mgr EMEA Compounding

Baxter International; Sesto Fiorentino; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A global healthcare company is seeking a Sterility Assurance Manager based in Sesto Fiorentino, Italy. This role will involve leading the development and implementation of sterility assurance strategies across EMEA compounding facilities. The successful candidate will act as a Subject Matter Expert, ensuring compliance with regulatory standards and driving continuous improvement. Candidates must possess a degree in Microbiology or Biotechnology, with at least 5 years of relevant experience in aseptic techniques. Proficiency in English is required, with additional language skills being a plus.

Competenze

• 5+ years of experience in microbiology in an aseptic facility.
• Proven leadership experience in multi-site or regional roles.
• Proficient knowledge of GMP and contamination management.

Mansioni

• Lead the development of sterility assurance strategies for EMEA.
• Ensure compliance with GMP and global standards.
• Evaluate new technologies for microbiological testing.

Conoscenze

Leadership in sterility assurance

Microbiology expertise

Regulatory compliance

Environmental monitoring

Aseptic techniques

Problem-solving skills

Knowledge of GMP

Team collaboration

Process improvement

Communication in English

Formazione

Degree in Microbiology or Biotechnology

Descrizione del lavoro

This is whereyour 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

• Act 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.

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