QA Operations Manager

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

In your role, you have the all-important task of providing Quality Assurance oversight to GMP manufacturing and testing operations for clinical drug substance, intermediates, and starting materials.

This includes quality oversight of technology transfer and disposition deliverables such as review of batch records, investigations, CAPAs, SOPs, test methods, change controls, and release of drug substance, intermediates, and starting materials (e.g. cell banks).  In addition to general QA oversight, you will be responsible for driving local implementation of electronic batch records, establishing and maintaining governing procedures, and providing global SME support as electronic batch records are deployed throughout PharmSci.  You will be relied on to support globally across PharmSci, partner lines, and Pfizer Global Supply to align goals and support the implementation of effective quality system solutions. Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation.

As a Manager, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It

• Represent BTxPharmSci at EBR Site Lead Meetings and offer quality insight for new technologies being developed/implemented

• Perform Quality Review and approve Master Template Records including built in properties 

• Offer Quality support during manufacturing runs and advise on how to fix issues within electronic batch records to stay compliant

• Have a thorough understanding of Master Control and how it impacts site quality and compliance requirements 

• Be the QA point of contact and SME for initial EBR implementations across multiple sites and business lines  

• Participate in stake holder meetings within Pfizer and with Master Control to contribute ideas to new developments specific to business lines 

• Have a thorough understanding of quality and compliance standards as it relates to Batch Records 

• Help develop, review, and approve new batch records within Master Control that support new manufacturing processes 

• Have a thorough understanding of pharmaceutical manufacturing to ensure batch records and Master Templates are compliant

• Participate in discussions and help make decisions of new features from Master Control to implement across BTxPharmSci 

• Contribute to the completion of complex projects, manage own time to meet agreed targets, and develop plans for work activities on own projects within a team.

• Review and/or approve various GMP documents, primarily batch records and investigations and including procedures, change controls, validation qualifications, and CAPAs. 

• Perform quality assurance disposition function for raw materials, in-process solutions, and/or production batches.

• Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.

• Participate on technology transfer teams reviewing and approving master batch records and related documentation.

• Support the site relative to a constant state of inspection readiness.

• Participate in audits relative to this role as needed.

• Make quality decisions to resolve moderately complex issues with minimal assistance from management.

• Recognize when an issue is beyond their sphere of influence and escalate immediately.  

• Present to peers/management locally or electronically.

• Contribute to quality assurance management team initiatives and objectives.