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 pharmaceutical microbiology principles, regulatory requirements, and applicable industry standards. 
• Demonstrated ability to analyze complex problems, lead investigations and develop sound, data-driven conclusions.   
• The ability to manage and supervise a team of employees.
• Proven leadership skills with the ability to effectively manage, engage and develop teams.  
• Excellent written and verbal communication skills, with the ability to collaborate effectively across multiple functional areas.
• Strong change leadership capabilities and experience supporting enterprise-level initiatives. 

Compensation

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $136,000 - 170,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than that of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply.

Applicants must be authorized to work for any employer in the U.S. We are un-able to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

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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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