Senior Manager, Quality - Microbiology Job at Baxter (Cleveland)

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.

Job Responsibility

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

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 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

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
educational assistance programs
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
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits

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Senior Manager, Quality - Microbiology

Job Description

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