QO Manager Compliance/TL

Pfizer • Rochester, MI

2d • $106,000 - $176,600 • Hybrid

About The Position

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. The candidate 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.

Requirements

• Bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Experience in a cGMP environment, with a strong working knowledge of a variety of quality systems, aseptic manufacturing and processes including Drug and Combination products.
• Demonstrated proficiency in organizational skills, balance multiple priorities, aptitude for technical learning, and problem solving.
• Understand regulatory requirements and audit strategy.
• Basic understanding of aseptic manufacturing.
• Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies.
• Knowledgeable in aseptic process/techniques, media simulations, air flow visualization, environmental monitoring, personnel monitoring, critical utility monitoring, sterilization processes, deviation investigation, and equipment/method validation.
• Ability to thoroughly evaluate quality investigations, deviations, laboratory investigations, and follow up actions are documented as they relate to the manufacturing, testing, distribution of raw materials, containers, closures, packing materials, labeling, in-process materials, and final product.
• Must NOT be allergic to penicillin.
• Must be able to aseptically gown.
• Permanent work authorization in the United States.

Nice To Haves

• Knowledge of drug/device combination product requirements is highly desirable.

Responsibilities

• 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.
• Oversee the 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, and support regulatory agency/corporate inspections.
• Act as a point of contact for regulatory inquiries.
• Ensure 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.
• Provide 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).
• Oversee the Validation Master Plan, Change Control Program, Quality Risk Management program, Sterility Assurance Assessments for investigations and changes controls, Media Simulation Program, air flow visualization program, sterilization qualification/requalification program, facility disinfectant and sanitization qualification program, and the Environmental and Personnel Monitoring Program.
• Provide 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 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).
• Compile and/or assess monthly and quarterly tracking/trending reports to ensure compliance with cGMPs and facility construction/maintenance requirements.
• Ensure systems are in place to assess impact to combination products and Data Integrity.
• Responsible for remediation of gaps and maintaining compliance between the on-market product and the Design History File (DHF) and Data Integrity as required.
• Provide oversight and guidance for risk management file lifecycle activities for combination products.
• Lead and facilitate risk assessment activities and guides design verification and validation plans.
• Evaluate changes that impact combination products, including change controls, complaints, sop revisions, and investigations associated with Post market surveillance.
• Lead the evaluation of adequacy and compliance of the site Quality Management System against all applicable medical device/combination product regulations and company policies and procedures.
• Evaluate supplier changes that impact combination products.
• Provide site technical guidance for combination product device changes, document updates, process changes, device risk management.
• Own risk management file documents/records.
• Lead the planning and implementation of Risk Management efforts, including establishing and revising system and procedures governing risk management.
• Review and establish link to the risk file for complex/significant CAPA, investigation and Change Management records.
• Facilitate risk assessment activities, risk mitigation strategies and risk management plans; provide review/approval as needed.
• Support day to day support for design changes, complaints, procedures, investigation, CAPA, management review.
• Lead the site’s Data Integrity Quality System, including development and leadership of appropriate governance, development and institution of requisite policies and procedures, establishment of sustainable and effective means of quality performance monitoring.
• Oversee the Data Integrity Program, Medical Device and Combination product program – conduct regulatory assessments, create/maintain design history file, participate and develop MDCP FMEAs, develop and report on key performance indicators (metrics), conduct internal audits, impact assess design changes.
• Oversee the CAPA Review Board (CRB).

Benefits

• 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
• Health benefits to include medical, prescription drug, dental and vision coverage
• Relocation support available

What This Job Offers

• Job Type: Full-time
• Career Level: Manager