Manager QA ADC

Pfizer • Pearl River, NY

8h • Onsite

About The Position

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients. In this role, you will: Provide QA support to Manufacturing and Laboratories Focus on Quality Systems including site Change Management Accountable for the overall management of the site Change Management process; acts as gate-keeper of the change by authorizing/approving the change from plan approval through implementation and closure Assess all changes for Regulatory impact by reviewing dossier content and collaborating with GCMC Regulatory Strategists as needed Initiate PCFs in PDM for regulatory impacted changes Author/approve Annual Product Review reports for commercial products Perform Informa linear regression analysis for stability trending for commercial products to meet ICH guidelines Support submission activities including authoring of stability content and review of CTD content; approves Forms 456 and 459. Create/approve stability protocols and product complaint investigations for commercial products. Acts as SME and Audit Escort/Host for BOH inspections Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues

Requirements

• Applicant must have a 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
• Substantial experience in pharmaceutical manufacturing and quality control
• Familiarity with Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects
• Knowledge of regulations related to vendor management programs and other industry quality systems
• Strong critical thinking skills and a proactive approach
• Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally
• Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms

Nice To Haves

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Knowledge or exposure to data science
• Strong leadership and team management skills
• Ability to work under pressure and meet tight deadlines
• Ability to influence and negotiate with stakeholders
• Experience in conducting internal audits and supporting regulatory inspections
• 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 QA support to Manufacturing and Laboratories
• Focus on Quality Systems including site Change Management
• Accountable for the overall management of the site Change Management process; acts as gate-keeper of the change by authorizing/approving the change from plan approval through implementation and closure
• Assess all changes for Regulatory impact by reviewing dossier content and collaborating with GCMC Regulatory Strategists as needed
• Initiate PCFs in PDM for regulatory impacted changes
• Author/approve Annual Product Review reports for commercial products
• Perform Informa linear regression analysis for stability trending for commercial products to meet ICH guidelines
• Support submission activities including authoring of stability content and review of CTD content; approves Forms 456 and 459.
• Create/approve stability protocols and product complaint investigations for commercial products.
• Acts as SME and Audit Escort/Host for BOH inspections
• Lead and guide moderately complex projects, managing time and resources effectively, and apply skills and discipline knowledge to departmental work
• Make decisions to resolve moderately complex problems, develop new options guided by policies, and operate independently in ambiguous situations
• Utilize judgment and experience to potentially become a resource for others, and evaluate clinical and commercial drug batches to ensure adherence to specifications
• Identify deviations in manufacturing and packaging processes, approve investigations and change control activities, and guide operational teams in project management
• Prepare forecasts for resource requirements, identify areas for improvement, and facilitate agreements between different teams using leadership skills
• Assess supplier operations for regulatory compliance, conduct quality reviews, and report results to relevant medical and quality groups
• Support the development of country quality strategic initiatives, lead continuous inspection readiness, and drive effective management of quality issues and CAPAs
• Participate in internal cGMP audits, support regulatory inspections, perform disposition of clinical trial materials, and communicate with internal and external customers to resolve project-related issues
• Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues

Benefits

• Benefits offered include a 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, and health benefits to include medical, prescription drug, dental and vision coverage.

What This Job Offers

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