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 designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contributions are crucial and 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 who rely on our products.

What You Will Achieve

You will be a member of Pfizer’s dedicated and highly effective quality assurance team. The QA Manager, Disposition is primarily responsible for oversight and final release of API, excipient and finished package product (Pharma/Device) for commercial distribution to domestic and international markets. This role will collaborate with a wide range of cross-functional groups on related quality activities including regulatory compliance, technical and systems, including the Focus Factory QA Leads. This can include but is not limited to material/ finished product disposition, documentation management and assessment of investigations, change control action items and audit action items. The manager must have fundamental knowledge of the principles and concepts of cGMPs of pharmaceutical manufacturing and the site production processes. The role ensures adherence to regulatory expectations and GxP. 

The QA Manager is responsible for colleague training and development and must motivate and inspire their team to ensure adherence to the Pfizer Core Values. Must be a critical thinker with the ability to effectively diagnose complex problems and identify sustainable solutions for technical challenges.

How You Will Achieve It

• Local Process Owner (LPO) for Batch Disposition Process (Revolution)
• Process Centric Team (PCT) Lead for QA Batch Disposition IMEx Tier 1
• Batch Record Disposition Training System owner
• Approves product specifications and COA updates
• Oversight of SAP QA activities and training
• Oversight of batch record documentation activities for ARCOS DEA requirements
• Owner Change Controls for the Disposition Process
• Perform review and approval Event Reports, QARs, CAPA, CCs actions/impact assessments
• Maintain completed in-process batch record packages until final release of finished product.
• Hire, train, develop and coach staff which includes setting direction and clear expectations for each direct report and provide routine feedback.   
• Attend / Co-lead Batch Tracker and Material Flow meetings.
• Maintain and provide data for the disposition metrics for daily/weekly releases.
• Supports the management finished batch documentation for archival
• Create and revise departmental Standard Operating Procedure (SOPs). 
• Review and approve site SOPs.
• Applies and removes Market Restrictions application and removal
•  Support internal/external audit preparation activities.
• Manages the Quality Alert Notices (QAN) processes.
• Participate in Quality Risk Management (QRM) assessments.
• Responsible for providing leadership, strategic planning, and oversight in the development and maintenance of the overall area processes.
• Support Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEx tools.  
• Participate in daily tier meetings as assigned.

Here Is What You Need (Minimum Requirements)

• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience  
• OR an Associate's degree with 8 years of experience  
• OR a Bachelor's with at least 4 years of experience  
• OR Master's Degree with more than 2 years of experience
• OR a PhD with 0+ years of experience
• Experience in parenteral or related drug manufacturing in pharmaceutical industry with a good understanding of global regulatory requirements.  
• Direct experience with conducting and/or reviewing and approving quality investigations.  
• Strong interpersonal skills and proven track record of teamwork, adaptability, innovation and initiative required.  
• Strong oral/written communications skills and leadership skills required. 
• Sound knowledge of current Good Manufacturing Practices (cGMP). 
• Exceptional interpersonal skills; demonstrate the ability to collaborate and communicate with all colleagues within the organization. 

Bonus Points If You Have (Preferred Requirements)

• ASQ certification
• Experience in production batch record review, investigation of nonconformance, root cause analysis, and change control management
• Strong attention to detail, excellent organizational, interpersonal and communication skills (oral and written)
• Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements

• Capable of rapidly absorbing technical data and ability to apply this knowledge to a pharmaceutical manufacturing environment.

PHYSICAL/MENTAL REQUIREMENTS

• Capable of standing for periods of more than one (1) hour.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Must be able to support during production 24/7 or 24/5 as required

Work Location Assignment: On Premise

The annual base salary for this position ranges from $102,900.00 to $171,500.00. 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. 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.

Quality Assurance and Control