12-18 Months)

Pfizer•Kalamazoo, MI

11h•Onsite

About The Position

This position will oversee the QC immunology lab in Kalamazoo, MI. The immunology lab performs bioanalytical testing supporting Atgam, Coral Snake Antivenom, Heparin and Thrombin. As the manager/TL of this lab you will lead the laboratory to meet defined quality standards and QO objectives ensuring that testing and investigations are appropriately prioritized and completed in order to support manufacturing and supply. You will work closely with the Atgam workstream project lead to provide testing support and alignment. You and your team will work to improve existing method robustness and accuracy.

Requirements

Bachelor's degree with at least 5 years of experience; OR a master's degree with at least 3 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.
Exceptional stakeholder and people management skill
Strong negotiation and effective communication abilities
Significant technical experience with quality systems, including change control, deviations, complaint management, documentation management, audits, and inspections
Strong technical writing and presentation skills
Excellent planning and organizing capabilities
Ability to manage multiple projects and ongoing work activities within the department
Permanent work authorization in the United States.

Nice To Haves

Demonstrated expertise in authoring, reviewing, and developing procedures or training materials
Experience in fostering a quality culture within an organization
Knowledge of Lean, Six Sigma, and Error reduction (PHP) tools
Experience in providing ongoing education on Quality to relevant functional groups
Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance

Responsibilities

Lead and manage people, technology, and financial resources within the department, ensuring alignment with short-term goals
Actively share knowledge and identify potential improvements in processes or products, taking risks to develop innovative ideas
Oversee operational activities and manage multiple projects involving cross-functional representatives
Recognize the need for development in others, collaborate to create development plans, and manage the performance of direct reports through goal setting, coaching, and ongoing assessment
Communicate effectively by soliciting input, explaining complex concepts, and persuading others to adopt a point of view
Support Manufacturing Operations by investigating and resolving batch deviations, implementing CAPAs, and monitoring the effectiveness of changes
Maintain Quality systems in accordance with GDP/GMP and internal standards, fostering a quality culture and aiming for continuous improvement
Apply technical knowledge of Operations, Quality, and Validation to provide input for improvements and support project objectives through document reviews and training
Coordinate and communicate project progress, manage contractors or supporting staff, forecast resources, and provide ongoing education on Quality to enhance the Quality Culture within the organization.