Sr Mgr/TL API Release Operations

USE YOUR POWER FOR PURPOSE

The Senior Manager/TL API Release Operations reports to the Quality Operations Director of Drug Product / API Quality Assurance and responsibilities include management oversight of the lot release, production deviation review, lab investigation review, batch record review teams, QO tech transfer, and supplier quality.

WHAT YOU WILL ACHIEVE

• Set objectives for and manage multiple projects/ ongoing work activities of high complexity within the API 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 API manufactured at the PGS-Kalamazoo plant.
• 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)

• Applicant must have a bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience.
• Experience in GMP-regulated industries in Manufacturing Operations.
• Process Validation with Quality Systems knowledge.
• 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, Microsoft Copilot, Claude, or Open AI to support problem solving.

  
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.

OTHER JOB DETAILS

Work Location Assignment: On Premise

Relocation support available

Last Date to Apply for Job: August 24, 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.




Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.






To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.


Quality Assurance and Control