Manager/TL Quality Control

Pfizer • Rochester, MI

16d • Onsite

About The Position

Use Your Power for Purpose This position will oversee the Quality Control Laboratory in Rochester, MI. The Rochester Quality Control Laboratory performs: Assay, Viscosity, Breakloose & Extrusion, Sterility, Gas chromatography, pH, LOD, Bacterial Endotoxin, Karl Fischer, and multiple other analytical technologies used to determine quality attributes for Rochester manufactured Drug Products. The selected candidate will lead the laboratory to meet defined quality standards and QO objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the laboratory and department. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and oversees colleague development. Provides oversight of department ensuring proper use of assets, budget, and personnel. What you Will Achieve Review and approve cGMP documentation to assure compliance with regulatory requirements. Assess deviation impacts and resolve to prevent future occurrences. Review and approve cGMP Changes in accordance with regulatory requirements. Review and approve training to assure cGMP requirements are met. Manage resources (people and assets) to meet work team goals. Support a continuous improvement culture where individuals can thrive in change. Thoroughly evaluate lab investigations, deviations, and associated corrective/preventive actions to ensure they are handled appropriately and documented effectively as they relate to the testing of raw materials, in-process samples, and final products. Assures adherence to data integrity initiatives. As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO. Supports and may lead implementation of various elements of IMEx.

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
• Previous experience with leading colleagues and/or projects is required.
• The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
• The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.
• All candidates applying must NOT be allergic to penicillin.
• This position requires permanent work authorization in the United States.

Nice To Haves

• The candidate should have experience in multiple of the following areas: cGMP, Regulatory, deviation investigations, drug product lot release, analytical method transfer/validation, process validation, laboratory testing, and laboratory investigations.

Responsibilities

• Review and approve cGMP documentation to assure compliance with regulatory requirements.
• Assess deviation impacts and resolve to prevent future occurrences.
• Review and approve cGMP Changes in accordance with regulatory requirements.
• Review and approve training to assure cGMP requirements are met.
• Manage resources (people and assets) to meet work team goals.
• Support a continuous improvement culture where individuals can thrive in change.
• Thoroughly evaluate lab investigations, deviations, and associated corrective/preventive actions to ensure they are handled appropriately and documented effectively as they relate to the testing of raw materials, in-process samples, and final products.
• Assures adherence to data integrity initiatives.
• As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO.
• Supports and may lead implementation of various elements of IMEx.

Benefits

• In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program.
• We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments.
• Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

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