Compliance Manager Jobs

About The Position

Requirements

• BA/BS and at least 4 years of experience; or MBA/MS and at least 2 years; or PhD/JD with any years of experience; or associate's degree and at least 8 years; or high school diploma/equivalent and at least 10 years of relevant experience.
• Experience in a cGMP environment, with strong working knowledge of quality systems and aseptic manufacturing and processes, including 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 the ability to share vision, direction, and data with colleagues at all levels, senior leadership, and regulatory agencies.
• Knowledge of aseptic processes and techniques, media simulations, airflow visualization, environmental and personnel monitoring, critical utility monitoring, sterilization, deviation investigations, and equipment and method validation.
• Ability to thoroughly evaluate quality investigations, deviations, and laboratory investigations, and ensure follow-up actions are documented for manufacturing, testing, and distribution of materials and products.
• Strong people-management experience.
• Strong computer proficiency, including MS Office, Word, Excel, Access, Project, and Trackwise or equivalent.
• Must not be allergic to penicillin.
• Must be able to aseptically gown.
• Must be able to lift 25–30 pounds.
• Must be authorized to work in the United States by any employer; 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, along with curiosity about their potential and understanding of responsible AI practices, risk management, and ethical use.

Responsibilities

• Lead a team responsible for Compliance, QA Documentation, Supplier Management, Validation, Sterility Assurance, Combination Product Quality, and Data Integrity.
• Provide guidance, coaching, direction, and approval of activities and decisions; oversee colleague development, performance, and quality-related issues.
• Write and deliver performance reviews and conduct second-level reviews as needed.
• Oversee department assets, budget, and personnel, and communicate with site and external customers and partners.
• Participate in internal, corporate, and agency audits and inspections, and serve as a point of contact for regulatory inquiries.
• Monitor and report quality metrics for monthly Site Quality Review Team and Management Review meetings.
• Manage and lead the site's Quality Improvement Plan and Inspection Readiness Program.
• Ensure site standards, policies, and procedures align with global Pfizer Quality Standards and regulatory agency guidance, and maintain a state of compliance and inspection readiness.
• Conduct internal site systems audits, monitor quality and compliance indicators, perform gap assessments, and address non-compliance.
• Coordinate the supplier management program and Medical Device & Combination Products 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 reports, and other GMP documents.
• Provide oversight of change control, validation, quality risk management, aseptic and microbiology support, and Medical Device & Combination Products programs.
• Oversee the Validation Master Plan, media simulation, airflow visualization, sterilization qualification and requalification, disinfectant and sanitization qualification, and environmental and personnel monitoring programs.
• Assess sterility assurance for investigations and change controls, and assist with events affecting aseptic quality, recovery of manufacturing areas to aseptic conditions, and microbial testing and qualification activities.
• Compile or assess monthly and quarterly tracking and trending reports to support cGMP compliance and facility construction and maintenance requirements.
• Ensure systems assess impacts to combination products and data integrity, remediate gaps, and maintain compliance between marketed products and the Design History File.
• Oversee combination-product risk management file lifecycle activities and lead risk assessments and design verification and validation planning.
• Evaluate changes affecting combination products, including change controls, complaints, SOP revisions, investigations, post-market surveillance, and supplier changes.
• Assess the site's Quality Management System for compliance with applicable medical device and combination product regulations and company procedures.
• Provide technical guidance on combination product device changes, document updates, process changes, and device risk management.
• Own risk management file documents and records; lead risk management planning and implementation, including governing systems and procedures.
• Review and link risk files to complex or significant CAPA, investigation, and change management records; facilitate risk assessments, mitigation strategies, and risk management plans.
• Support day-to-day design changes, complaints, procedures, investigations, CAPA, and management review.
• Lead the site's Data Integrity Quality System, including governance, policies and procedures, and sustainable quality-performance monitoring.
• Lead or support the CAPA Review Board and the Medical Device and Combination Product program, including regulatory assessments, Design History File maintenance, FMEAs, performance metrics, 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.
• Eligibility for participation in Pfizer's Global Performance Plan with a bonus target of 15% of base salary.
• Eligibility to participate in a share-based long-term incentive program.
• Relocation assistance may be available based on business needs or eligibility.