QO Manager Compliance​/TL

USE YOUR POWER FOR PURPOSE

Candidate will lead a team of Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity within the Rochester Quality organization.

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.

• Provide guidance, coaching, and direction to QO colleagues; oversee activities, decisions, and performance reviews.
• Oversee the department to ensure proper use of assets, budget, and personnel; communicate effectively with key customers and partners inside and outside the site.
• Coordinate cross‑departmental and company interactions and participate in internal corporate and agency audits/inspections.
• Monitor and report quality metrics for the site’s monthly Site Quality Review Team / Management Review meetings.
• Lead the site’s QIP (Quality Improvement Plan) and IR (Inspection Readiness) Program.
• Ensure site standards, policies, and procedures align with global Pfizer Quality Standards and regulatory guidance.
• Maintain inspection readiness through internal site systems audits, compliance/quality performance indicator metrics, gap assessments, and non‑compliance remediation.
• Coordinate the supplier management program, MDCP activities, investigate product complaints, and generate annual product reviews.
• Manage the QA Documentation department processes for SOPs, master batch records, specifications, test methods, OJTs, validation protocols/reports, technical protocols, and other GMP documents.
• Oversee Validation and Sterility Assurance programs, including change control, validation, quality risk management, aseptic and microbiology support, and MDCP.
• Provide oversight of environmental and personnel monitoring, event containment, and return of manufacturing areas to aseptic conditions.
• Ensure compliance of combination products and Data Integrity through gap remediation and risk management file lifecycle activities.
• Lead the site’s Data Integrity Quality System, develop governance, policies, procedures, and monitor quality performance.

• 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

• Must not be allergic to penicillin (must be able to self‑gown aseptically).
• Must be able to lift 25‑30 lbs.

• Non‑standard work schedule may be required, including evening, weekend, and night shifts.
• Minimal travel for mandatory training/seminars.
• Relocation assistance may be available based on business needs.
• Must be authorized to work in the U.S.; self‑employment not mandatory.
• Must not accept mandatory self‑employment, self‑employment mandates must not be mandatory.

The annual base salary ranges from $ to $, with eligibility for participation in Pfizer’s Global Performance Plan and long‑term incentive programs. Benefits include 401(k) with matching contributions, paid vacation, holiday, personal days, mandated medical, dental, and vision coverage. Relocation assistance may be provided.

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