QO Manager Compliance/TL

Pfizer • Rochester, MI

5d • Onsite

About The Position

The QO Manager Compliance/TL provides leadership for the Rochester Quality organization, managing a team with responsibilities spanning Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity. The role provides coaching and direction to colleagues, oversees performance and development, reviews performance, and ensures appropriate use of department assets, budget, and personnel. It works with customers and partners across the site and company, participates in internal, corporate, and regulatory audits and inspections, and reports quality metrics at the monthly Site Quality Review Team/Management Review meeting. The role also leads the site’s Quality Improvement Plan (QIP) and Inspection Readiness (IR) Program.

For Compliance, QA Documentation, and Supplier Management, the manager ensures site standards and procedures align with Pfizer Quality Standards and regulatory guidance and that operations remain compliant and inspection-ready. This includes internal systems audits, compliance metrics, gap assessments, corrective follow-up, supplier management, Medical Device and Combination Products (MDCP) activities, product complaint investigations, annual product reviews, and oversight of QA documentation processes and GMP documents. The manager supports regulatory and corporate inspections and serves as a point of contact for regulatory inquiries.

For Validation and Sterility Assurance, the manager oversees programs involving change control, validation, quality risk management, aseptic and microbiology support, environmental and personnel monitoring, facility cleaning and sanitization, sterilization, media simulations, microbial tracking and trending, and MDCP. The role maintains the Validation Master Plan and relevant qualification programs, supports aseptic investigations and recovery of manufacturing areas following shutdowns or breaks in asepsis, and assesses tracking and trending reports for compliance with cGMP and facility requirements.

For Combination Product Quality and Data Integrity, the manager ensures systems assess product and data-integrity impacts, remediates gaps, and maintains compliance between marketed products and Design History Files. Responsibilities include oversight of combination-product risk management files, risk assessments, design verification and validation plans, supplier and product changes, quality-system compliance assessments, and day-to-day support for design changes, complaints, investigations, CAPA, and management review. The role leads the site Data Integrity Quality System and the combination-product program, including regulatory assessments, Design History File maintenance, FMEAs, performance metrics, internal audits, and design-change impact assessments.

This is an on-premise position at a penicillin manufacturing facility. Candidates must not be allergic to penicillin and must be able to aseptically gown and lift 25–30 pounds. Non-standard hours may sometimes be required to support product release, including weekend, second-shift, or night-shift work and calls for process decisions. Travel for training or seminars is minimal. The role is eligible for a performance bonus and participation in a share-based long-term incentive program. Relocation assistance may be available based on business needs and eligibility. Applicants must be authorized to work in the United States; visa sponsorship is unavailable.

Requirements

• Bachelor's degree with at least 4 years of experience; or MBA/MS with at least 2 years; or PhD/JD with any years of experience; or associate's degree with at least 8 years; or high school diploma or equivalent with at least 10 years of relevant experience.
• Experience in a cGMP environment and strong working knowledge of quality systems, aseptic manufacturing and processes, and drug and combination products.
• Demonstrated organizational skills, ability to balance multiple priorities, technical learning aptitude, and problem-solving ability.
• Understanding of regulatory requirements and audit strategy.
• Basic understanding of aseptic manufacturing.
• Excellent written and verbal communication skills, including ability to communicate vision, direction, and data across work groups and levels, including senior leadership and regulatory agencies.
• Knowledge of aseptic processes and techniques, media simulations, air-flow visualization, environmental and personnel monitoring, critical utility monitoring, sterilization processes, deviation investigation, and equipment and method validation.
• Ability to evaluate quality investigations, deviations, laboratory investigations, and follow-up actions related to manufacturing, testing, and distribution of materials and products.
• Strong people-management experience.
• Proficiency with MS Office, Word, Excel, Access, Project, and Trackwise or equivalent.
• Must not be allergic to penicillin, must be able to aseptically gown, and must be able to lift 25–30 pounds.
• Must be authorized to work in the United States; U.S. work visa sponsorship is not available.

Nice To Haves

• Understanding of device and combination-product industry regulations.
• Strong analytical and problem-solving skills.
• Ability to work independently and make decisions.
• Excellent organizational and time-management skills.
• Experience interfacing with regulatory agencies during audits.
• Ability to drive continuous improvement initiatives.
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and productivity, with curiosity about their use and understanding of responsible AI practices, risk management, and ethical use.

Responsibilities

• Lead and manage teams responsible for Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity.
• Coach and guide colleagues, direct or approve activities and decisions, reinforce group values and behaviors, and oversee development, performance, and quality-related issues.
• Write and deliver performance reviews and conduct second-level reviews as required.
• Oversee department assets, budget, and personnel.
• Communicate with site and external customers and partners, and participate in internal, corporate, and regulatory audits and inspections.
• Monitor and report quality metrics for monthly Site Quality Review Team/Management Review meetings.
• Lead the site Quality Improvement Plan (QIP) and Inspection Readiness (IR) Program.
• Ensure site standards, policies, procedures, and quality systems align with Pfizer Quality Standards and regulatory guidance and remain compliant and inspection-ready.
• Conduct internal site systems audits, monitor quality and compliance metrics, perform gap assessments, and address non-compliance.
• Coordinate the supplier management program and MDCP activities; investigate product complaints and generate annual product reviews.
• Manage QA Documentation processes for SOPs, master batch records, specifications, test methods, OJTs, validation protocols and reports, technical protocols, and other GMP documents.
• Support regulatory agency and corporate inspections and serve as a point of contact for regulatory inquiries.
• Oversee validation, change control, quality risk management, aseptic and microbiology support, environmental and personnel monitoring, sterilization, media simulation, and microbial tracking and trending programs.
• Maintain the Validation Master Plan, air-flow visualization program, sterilization qualification and requalification program, and facility disinfectant and sanitization qualification program.
• Oversee environmental and personnel monitoring and provide guidance on aseptic-quality events, risk mitigation, and restoring manufacturing areas to aseptic conditions after shutdowns or breaks in asepsis.
• Support microbial testing and qualification activities and compile or assess monthly and quarterly tracking and trending reports.
• Ensure systems assess combination-product and Data Integrity impacts, remediate gaps, and maintain compliance between marketed products and Design History Files.
• Oversee combination-product risk management files and facilitate risk assessments, mitigation strategies, management plans, and design verification and validation planning.
• Evaluate changes affecting combination products, including change controls, complaints, SOP revisions, investigations, supplier changes, and post-market surveillance activities.
• Assess site Quality Management System adequacy and compliance against applicable medical-device and combination-product regulations and company policies.
• Lead and maintain risk-management documentation and processes, including risk-file links for significant CAPA, investigations, and change-management records.
• Lead the site's Data Integrity Quality System, including governance, policies and procedures, and quality-performance monitoring.
• Lead the combination-product program, including regulatory assessments, Design History File maintenance, MDCP FMEAs, performance indicators, internal audits, and design-change impact assessments.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer retirement savings contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligible for participation in Pfizer’s Global Performance Plan, with a 15% target bonus of base salary.
• Eligible to participate in Pfizer’s share-based long-term incentive program.
• Relocation assistance may be available based on business needs and eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: High school or GED