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Sr Manager Micro Lab and Sterility Assurance

Req # JR - 173405 Location Lessines, Wallonia, Belgium Job Category Quality Date posted 05/20/2025
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Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/ Professional Development

  • Employee Heath & Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

Sr Manager Micro Lab and Sterility Assurance

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This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

The role

You will be responsible of managing the activities of the microbiological laboratories ensuring compliance with the required time and quality standards including rigorous microbiological testing, risk assessment, and contamination control within the manufacturing site

You will act as the Facility Sterility Assurance for the operation of the manufacturing site.

Essential Duties & Responsibilities

  • Develop and implement sterility assurance strategies, policies, and procedures for the manufacturing site.
  • Develop and implement microbiological strategies, policies, and procedures including environmental monitoring, microbiological testing, and microbial identification; including identification of gaps, resolution of discrepancies, and development of action plans
  • Oversee the microbiology laboratory, including managing a team of microbiology professionals, scheduling, and prioritizing testing activities, and ensuring timely and accurate release of products.
  • Ensure compliance with regulatory requirements and industry standards, such as FDA, EMA, PICs, USP and ICH guidelines.
  • Assess impact of new regulations and implement appropriate changes as well as lead development of process flows and procedures.
  • Maintain the company's sterile manufacturing operations, including cleanroom facilities, solution transmission system and sterilization processes. Monitor the results of microbiological tests and environmental monitoring to prevent contamination and provide technical support to the appropriate preventive or corrective measures.
  • Provide direct supervision of individuals including mentoring, performance management and staffing decisions. Ability to manage/supervise a large team of employees. Develop a successor and a qualified work team aligned with the company's needs
  • Conduct risk assessments and root cause analyses for sterility assurance and microbiology issues and develop corrective and preventive actions to address them.
  • Develop and maintain strong relationships with cross-functional teams, including manufacturing, quality control, and research and development, to ensure effective communication and coordination of microbiology activities.
  • Collaborate with cross-functional teams to ensure effective communication and coordination of sterility assurance activities.
  • Participate in regulatory inspections and audits and respond to inquiries and observations from regulatory authorities.
  • Manages department budget focusing on management of cost controls and cost reduction activities.
  • Stay up to date with the latest industry trends, developments, and standard methodologies in sterility assurance and microbiology.
  • Establish metrics and key performance indicators (KPIs) and ensure appropriate data is available to measure the effectiveness of micro lab and track progress towards quality goals.

Qualifications

  • Master's degree in a relevant scientific discipline ( microbiology, pharma or biologie); advanced degree preferred.
  • Minimum of 10 years of experience within the pharmaceutical industry or Biotech, in microbiology or sterility assurance.
  • Relevant experience in people management

  • Fluency in French and English is a must

  • Team spirit

  • Problem-solving and analytical skills

  • Critical and inquisitive mind

  • Respectful of rules and procedures

  • Rigorous, with organizational and planning skills

  • Excellent communication and presentation skills

  • Resistant to stress & demonstration of flexibility in times of change

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.

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Address

Explore this location Rue Rene Branquart, 80
7860 Lessines
Belgium Explore This Location

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

“I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need.”

Meet Lorena, Senior QA Associate in London, UK

“I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety.”

Meet Gary, Quality Research Manager in Singapore

“I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission.”

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