Sr Manager Micro Lab and Sterility Assurance

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.

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