Use Your Power for Purpose
The Senior Manager/TL Drug Product Release Operations reports to the Quality Operations Director of Drug Product Quality Assurance and responsibilities include management oversight of the lot release, production deviation review, lab investigation review, and batch record review teams.
What You Will Achieve
Set objectives for and manage multiple projects/ ongoing work activities of high complexity within the Drug Product Quality Assurance Business Unit.
Manage and lead people, technological and financial resources within the Quality Assurance Business Unit.
Leads the Quality Assurance teams supporting release for all finished dosage forms manufactured at the PGS-Kalamazoo plant which includes sterile injectables, non-sterile liquids/semi-solids, biologics, and Class I and Class III medical devices.
Actively support the successful completion of regulatory and customer audits, may serve as audit host during on-site regulatory inspections.
Review and approve various compliance documents including regulatory submissions, deviations, validation reports, stability reports, internal audits, Annual Product Reviews, and SOPs. Lead the identification and initiation of continuous process improvements to enhance the quality of operations, systems and services evaluating compliance with applicable GMP/GDP requirements.
Support the investigation of and implementation of corrective/preventive actions for, quality issues.
Lead/Participate on cross functional projects teams and share knowledge and best practices with Medical and Pfizer counterparts.
Set expectation for goal setting, ongoing assessment, coaching, performance development and evaluation to motivate direct and indirect reports to develop and maintain a team of highly qualified and diverse personnel that deliver results for department or business line.
Oversee the training needs of colleagues and alliance partners with regards to procedures, policies and systems and the development of training plans to meet the needs of the business.
Here Is What You Need (Minimum Requirements)
BA/BS with 6+ years of experience or MBA/MS with 5+ years of experience or PhD/JD with 1+ year of experience or MD/DVM with any years of relevant experience
Experience in GMP-regulated industries in Manufacturing Operations
Process Validation with Quality Systems knowledge
Previous experience in a role involved in the drug development process
Demonstrated record of successful interaction with global regulatory and other internal and external auditing groups
Thorough understanding of the technical and commercial aspects of pharmaceutical API / Drug products
Excellent verbal and written communication skills
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact
Bonus Points If You Have (Preferred Requirements)
Solid understanding of training design and tools and experience in applying effective training methodologies
Experience in managing cross-functional teams
Strong analytical and problem-solving skills
Ability to work in a fast-paced, dynamic environment
Excellent organizational and project management skills
Strong leadership and team-building skills
Experience in developing and implementing strategic initiatives
Experience using common AI tools, including generative technologies such
as ChatGPT or Microsoft Copilot, to support problem solving and enhance
Work Location Assignment: On Premise
Last Day to Apply: March 30, 2026
The annual base salary for this position ranges from $139,100.00 to $231,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% 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. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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