Sr Manager, Quality - Microbiology

• 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

• 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

A graduate degree in Microbiology or related field is desirable

• 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), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• 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
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits