QA Manager, ADC Operations

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients.  Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

As a QA Manager, ADC (Antibody–drug conjugates) Operations, you will be a member of Pfizer’s dedicated and highly effective quality assurance team. Responsible for providing quality assurance support to Manufacturing and Testing Operations relative to the production of commercial and/or clinical products.  Review batch records; assign disposition (approval, rejection, etc.) to the material produced and incoming raw materials, approve investigations for discrepancies; review, edit, and approve protocols and reports, and author, review, and approve SOPs.  Perform shop floor activities such as line clearance and AQL inspections. Review and audit logbooks and other shop floor records.  Observe shop floor behavior and coach as required. Manage the Quality Agreement process. Independently execute projects/studies/review and analyze, interpret and present the data.  Plan work independently and consult with manager as needed.  Incumbent knows and applies fundamental technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant Pfizer SOPs.  Participate in Regulatory inspections, assist in managing the change management system and assure all process or other GMP changes are made utilizing the change management system. 

It is your problem solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Review batch records and perform disposition of commercial and clinical trial materials.
• Overseeing Shopfloor activities and providing coaching and guidance when needed.
• Manage incoming material disposition and sampling plans.
• Manage Quality Agreements process ensuring Quality Agreement requirements are met and meet Pfizer expectations.
• Assist in management of the Change Control process.
• Review and approve manufacturing investigations ensuring impact, root cause and corrective actions are appropriate.
• Conduct quality reviews of SOPs, LABs, Change Notifications (CNs), protocols and reports.
• Provide guidance, lead/co-lead projects, manage own time to meet objectives.
• Contribute to Quality Assurance by undertaking a variety of roles or assignments to further develop internal processes.
• Make decisions that may involve complex quality and technical issues.
• Participate in internal Good Manufacturing Practices {cGMP} audits and support regulatory inspections or corporate audit activities.
• Participate as a member of the Aseptic Processing Team (APT)

Qualifications

Must-Have

• Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience;
• OR an Associate's degree with eight years of experience;
• OR a Bachelor’s degree with at least 5+ years of experience;
• OR a Master’s degree with more than three years of experience;
• OR a Ph.D. with 0+ years of experience.
• Experience/education in microbiology and aseptic processing
• Pharmaceutical manufacturing
• Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
• Proactive approach and strong critical thinking skills
• Strong collaboration, relationship management, and interpersonal skills
• Excellent written and verbal communication
• Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as SAP, LACES/LIMS, Quality Tracking System, Trackwise, and Documentum platforms