Manager/Team Lead, Quality Lab Operations

Use Your Power for Purpose

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for operational oversight of the analytical chemistry testing laboratories that perform quality control and stability testing of Final Active Ingredients, Final Drug Products and Raw Materials at the Kalamazoo site. Your contribution to analytical testing and any associated investigational support will help Pfizer provide safe drugs to patients.  Your understanding of Quality Control (QC) instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D). 

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your expertise will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.  It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Manage multiple projects and ongoing work activities of moderate complexity within the division typically involving cross-functional representatives.

• Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

• Review and approve documentation associated with Good Manufacturing Practices {also cGMP}, method validation, investigation of change controls and technical reports.

• Collaborate with site functional areas and customers to support site goals, objectives and timelines.

• Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support for all testing activities in the routine testing area.

• Provide oversight of chemistry product testing group responsible for routine testing of product or process samples for final APIs, Drug Products and Raw Materials.

• Oversee project management of all Data Integrity related activities with the relevant teams.

• Address and resolve any potential issues with regulatory impact.

• Develop and maintain alignment with current industry best practice related to cleanroom techniques and share with the respective teams.

• Represent area of responsibility at meetings and in audits.

• Provide information, discuss problem batches, manufacturing/technical issues, deviations and other events with potential impact on product quality and/or supply.

• Foster teamwork and colleague development, as well as change management, within the department and set up departmental metrics to achieve operation effectiveness.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

• Demonstrated experience in Quality Control

• Experience with analytical testing.

• Extensive knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories, application of compendial methods and experience with a wide range of analytical techniques

• Reasoning ability including strong analytical and problem solving abilities

• Strong people management experience

• Strong verbal and written communication skills

Bonus Points If You Have (Preferred Requirements)

• Knowledge in the application of statistical tools, root cause analysis, and/or six sigma methodologies

• Expertise in Quality Control (QC) instruments and accuracy specifications

• Experience in setting requirements for the transfer of methodology from Research and Development (R&D)

• Ability to manage projects and ongoing w