Sterility Assurance Sr Mgr EMEA Compounding

Baxter International; Stockport; On-site; GBP 60,000 - 85,000; Full time

Job summary

A healthcare company in Stockport is seeking a Sterility Assurance Manager to oversee the sterility assurance strategies in the EMEA region. This role involves leading initiatives to maintain compliance with regulatory standards and ensuring effective environmental monitoring. Ideal candidates will have a background in microbiology, 5 years of experience in aseptic manufacturing, and strong leadership skills. The position offers a competitive compensation and professional development opportunities.

Benefits

Competitive total compensation package

Professional development opportunities

Work life balance

Qualifications

• Experience of aseptic techniques in the pharmaceutical or biotechnology industry.
• 5+ years of microbiology experience in an aseptic facility is preferred.
• Experience with regulatory inspections in the EU.

Responsibilities

• Develop and implement sterility assurance strategies across EMEA compounding sites.
• 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.

Skills

Microbiology knowledge

Leadership experience

GMP knowledge

Aseptic techniques

Contamination management

Regulatory compliance

Language skills (English, French, Italian)

Education

Degree in Microbiology or Biotechnology

Job description

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.

Sterility Assurance Manager EMEA

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

What are some of the benefits of working at Baxter?

• Competitive total compensation package
• Professional development opportunities
• High importance placed on work life balance

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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