QO Manager Compliance/TL (Secondment 12-18 Months)

Pfizer•Rochester, MI

4d•Onsite

About The Position

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.

Requirements

Bachelor's degree with at least 5+ years of experience; OR a master's degree with at least 3+ 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.
Working knowledge of current Good Manufacturing Practices (cGMP) for a pharmaceutical industry.
Extensive knowledge of corporate quality systems that are applicable to the quality unit and the production operations serviced.
Strong collaboration, relationship management, and interpersonal skills.
Strong people management experience.
Excellent written and oral communication skills.
Strong computer proficiency skills in MS Office, Word, Excel, Access, Project, Trackwise or equivalent.
Understand regulatory requirements and audit strategy.
Basic understanding of aseptic manufacturing.
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.
Candidates must be authorized to be employed in the U.S. by any employer.
This position requires permanent work authorization in the United States.

Nice To Haves

Master's degree with a solid 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 in 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 enhance productivity.
Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.

Responsibilities

Provide leadership 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.
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.
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.
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).
Responsible to 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.
Leads and facilitates risk assessment activities and guides design verification and validation plans.
Evaluates changes that impact combination products, including change controls, complaints, sop revisions, and investigations associated with Post market surveillance.
Leads 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.
Owner for risk management file documents/records.
Leads 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.