Sr Manager, Quality - Microbiology

This is where your 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. 

Job Description

At Baxter Healthcare Corporation, we are deeply committed to improving patient outcomes through the delivery of high-quality, compliant and innovative healthcare solutions.  As Senior Manager, Quality—Microbiology, based in Cleveland, MS, you will provide strategic and operational leadership for the Microbiology Laboratory, ensuring full compliance with regulatory requirements  and Baxter quality standards  and procedures. This role offers an exceptional  opportunity to lead a high-performing team within an organization where quality, integrity and continuous improvement are core values. 

Your Role at Baxter

 In this role, you will be accountable for the effective leadership, performance and compliance of the microbiology laboratory including but not limited to the following responsibilities:

• Provide overall direction and leadership for microbiology laboratory operations to ensure  results consistently meet  product quality, safety, and performance standards.
• Implement, maintain and continuously improve quality systems and procedures to ensure compliance with Baxter policies and regulatory requirements.
• Ensure full compliance with applicable regulations in the  including FDA, USP and cGMP requirements within the microbiology laboratory.
• Serve as a primary quality microbiology liaison during regulatory inspections; lead preparation activities and develop effective, timely responses to regulatory observations.   
• Lead and participate in internal and external supplier quality audits and assessments to identify compliance gaps, assess risk, and implement corrective action plans.
• Identify, prioritize and manage continuous improvement initiatives that enhance quality, reliability , efficiency and cost effectiveness.  
• Develop, revise and implement laboratory procedures, methods and techniques to ensure alignment with current operational and regulatory standards. 
• Ensure laboratory safety, cleanliness, and biosafety compliance in accordance with Good Laboratory Practices (GLP) and biosafety requirements; promote a strong safety culture.
• Review and approve laboratory data, test results, and documentation to ensure accuracy, data integrity and compliance with cGMP and company policies.
• Oversee  laboratory  inventory management, including supply forecasting, receipt verification, and invoice approvals.
• Coordinate daily departmental workflow  and ensure effective allocation of resources to support timely product release. 
• Develop and support career paths and professional growth opportunities for microbiology staff.
• Manage department to ensure timely release of products to meet company and customer quality requirements.
• Lead investigations related to nonconformances and deviations; ensure robust root cause analysis and implementation of effective corrective and preventive actions (CAPA).Develop,  manage and control the department budget while ensuring alignment with business and quality objectives.
• Recruit, mentor, train and develop microbiology personnel; support succession planning and professional growth to build a strong and sustainable team.  Promote and sustain a clean, organized and safe work environment  using 6S principles.
• Maintain expert-level knowledge of applicable quality and regulatory standards and ensure team members receive appropriate training to strengthen regulatory and quality awareness.  .

What you'll bring

To be successful in this role, you will need:

• A BS degree or equivalent experience, preferably in Microbiology, Biology, Chemistry, or related scientific discipline or equivalent relevant experience and at least 30 semester hours of microbiology coursework.  A graduate degree in Microbiology or related field is desirable.
• A minimum of 10 years of professional experience in pharmaceutical or regulatory microbiology environments including at least 5 years of people management or supervisory experience.
• In-depth knowledge of phar