Sr Manager, Quality - Microbiology

Baxter • Cleveland, OH

23h • $136,000 - $170,000

About The Position

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:

Requirements

• 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 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.

Nice To Haves

• A graduate degree in Microbiology or related field is desirable.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees