QO Manager Compliance/TL

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 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

Candidate will be responsible to provide leadership for will be responsible for managing a team of Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity within the Rochester Quality organization.

Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and performs second level reviews as required. Provides oversight of department, ensuring proper use of assets, budget, and personnel. Communicates effectively with key customers and partners, both within the site and outside of it.

This role will require cross departmental and company interactions as well as participates in internal, corporate, and agency audits/inspections. Monitors and reports quality metrics for the site’s monthly Site Quality Review Team/Management Review meeting. Manage and lead for site’s QIP (Quality Improvement Plan) and IR (Inspection Readiness) Program.

This position leads a team of individual contributor direct reports with a wide range of quality responsibilities including; Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity.

Compliance, QA Documentation, Supplier Management: Candidate will ensure that site standards, policies and procedures are aligned with global Pfizer Quality Standards, regulatory agency’s guidance’s and are operating in a state of compliance. Ensure that Rochester remains in an inspection readiness state by conducting internal site systems audits, monitoring and generating compliance/quality performance indicator metrics, performing gap assessments and addressing any areas of non-compliance. Coordinates supplier management program, Medical Device & Combination Products (MDCP) activities, investigates product complaints, and generates annual product reviews. Manages QA Documentation department involving processes for SOPs, master batch records, specifications, test methods, OJTs, validation protocols/reports, technical protocols, reports, and other GMP documents.

· PQS (Pfizer Quality Standards)

· Site Inspection Readiness Program

· FARs and AQRT Programs

· Site Internal Audit Program

· Balanced Score Card and MDCP Metrics

· Site Quality / Management Review Team Meetings

· Supplier Management Program

· QA Documentation Control Program

· Support regulatory agency/corporate inspections

· Point of contact for regulatory inquiries

Validation and Sterility Assurance: Candidate will be responsible for ensuring that the sites Validation and Sterility Assurance standards, policies and procedures are aligned with global Pfizer Quality Standards and regulatory agency’s guidance’s and are operating in a state of control. Responsible for providing oversight of the following programs: change control, validation, quality risk management, aseptic and microbiology support (processing, technique/clean room behaviors, environmental/critical utilities/personnel monitoring, facility cleaning and sanitization, sterilization, media simulation, microbial tracking/trending), and Medical Device & Combination Products (MDCP).

· Validation Master Plan

· Change Control Program

· Quality Risk Management program

· Sterility Assurance Assessments for investigations and changes controls

· Media Simulation Program

· Maintain the sites air flow visualization program

· Maintain the sterilization qualification/requalification program

· Maintain the facility disinfectant and sanitization qualification program

· Provide oversight of the Environmental and Personnel Monitoring Program

· Provide assistance/oversight for the resolution regarding events that impact the aseptic quality to assure event is contained and appropriate steps are taken to mitigate risk to product and the environment

· Provide assistance/oversight with coordinating activities to return manufacturing areas to aseptic conditions following plant shutdowns or break in asepsis

· Provide assistance with general microbial testing/qualification activities (Raw material, In-process, Product and Shelf Life product testing and critical utilities monitoring)

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