Sterility Assurance Manager EMEA

Baxter; Monza; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

A global healthcare company is seeking a Sterility Assurance Manager in Monza, Italy, to lead the development and implementation of sterility assurance strategies across EMEA. The successful candidate will ensure compliance with GMP regulations while promoting a culture of continuous improvement and innovation. Required qualifications include a microbiology or biotechnology degree and 5+ years of relevant experience. The role offers an opportunity to make a meaningful impact in healthcare delivery.

Competenze

• Validated experience in sterility assurance or aseptic manufacturing in pharma/biotech.
• Proficient knowledge of GMP aseptic methods and contamination management.
• Proven leadership experience in multi-site or regional roles.

Mansioni

• Lead sterility assurance strategies across EMEA compounding sites.
• Collaborate with regulatory agencies during inspections.
• Promote quality and continuous improvement in all activities.

Conoscenze

Quality Assurance

FDA Regulations

ISO 9001

Quality Management

Microbiology Aseptic Techniques

Formazione

Microbiology or Biotechnology Degree

Descrizione del lavoro

This is where your work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou 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 Baxters 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.

Recruitment Fraud Notice

Baxter 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.

Required Experience : Manager

Key Skills

Quality Assurance, FDA Regulations, Food Industry, Food Safety Experience, ISO 9001, Quality Systems, Food Processing, Quality Control, Quality Management, QA / QC, Selenium, HACCP

Employment Type

Full‑Time

Experience

years

Vacancy

1