QC Manager, Stability
PfizerAbout the role
Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is flexible, innovative, and customer-oriented. Whether you are engaged in development, maintenance, compliance, or analysis through research programs, your contribution will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. Join us in our mission to improve patient outcomes through excellence in every aspect of our work.
The Quality Control Stability Manager is responsible for the management of Stability group to ensure that quality control cGMP activities in support of the clinical and commercial stability testing of products manufactured at the Sanford site are conducted within site, corporate, and regulatory requirements. The scope of the position includes all activities associated with stability studies and QA reserve samples for multiple types of products.
What You Will Achieve
In this role, you will:
Provides strategic and scientific oversight to the stability team
Ensures Stability studies are managed and handled per site and global procedures and guidelines
Responsible for colleagues objective setting, conducting one on one meetings with Colleagues, providing guidance/coaching, assisting with colleague development planning, and completing performance reviews
Determines appropriate training curriculums for colleagues
Responsible for review, approval and final authorization of cGXP documentation (e.g. data records, reports, protocols, batch records, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
Manage a working area and manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines
Responsible for participating in, leading, or providing guidance for investigations
Serve on or leads cross functional teams to represent QC stability and facilitate communications and activities/projects between Quality Operations and site departments and/or Network
Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation
Plans and leads complex, high business impact projects to ensure their timely completion
Established interpersonal skills (negotiation, managing conflict) to influence team
Work is achieved by individual or through project teams, utilizing technical or subject matter expertise to achieve results
Requires relevant scientific education, skills, and knowledge
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 experienceExperience in QC/laboratory management
Previous leadership experience required, and experience leading people leaders is preferred
Strong background in Quality Control
Extensive knowledge of Good Manufacturing Practices (cGMP) compliance requirements for Quality Control Laboratories
PHYSICAL/MENTAL REQUIREMENTS
Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.
Limited travel for the position; no more than 15% traveling.
OTHER JOB DETAILS
Last Date to Apply for Job: August 20, 2025.
Referral Bonus Eligibility: YES
Eligible for Relocation Package: NO
Relocation support available
Work Location Assignment: On Premise
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