WHY PATIENTS NEED YOU

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.

HOW YOU WILL ACHIEVE IT

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 forthe 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).

• Compile and/or assess monthly and quarterly tracking/trending reports to ensure compliance with cGMP s and facility construction/maintenance requirements.

Combination Product Quality/Data Integrity:

Candidate will be 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.

• Data Integrity Program.

• CAPA Review Board (CRB).

• 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.

QUALIFICATIONS

Must-Have

• Applicant must have a 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.

Nice-to-Have

• 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.

PHYSICAL/MENTAL REQUIREMENTS

• This is a penicillin manufacturing facility.  All candidates applying mist NOT be allergic to penicillin.

• Must be able to aseptically gown.

• Able to lift 25-30 lbs.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions.

• Minimal travel for training/seminars.

OTHER JOB DETAILS

• Last Date to Apply for Job: September 24, 2026

• Additional Location Information: NA

• Eligible for Relocation Package – NO

• Secondment 12-18 months

• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment.  Please refer to the Fleet Policy and Procedures document for more information.

• There will be no change to your current work location.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.