MQA Technical Lead

Pfizer • Sanford, NC

422d • $99,900 - $166,500

About The Position

The Manufacturing Quality Assurance (MQA) Technical Lead at Pfizer plays a critical role in ensuring compliance with regulatory requirements and quality standards in the manufacturing process. This position involves leading a team responsible for Quality Assurance activities on the manufacturing floor, evaluating clinical and commercial batches, and providing guidance to operational teams. The role emphasizes adherence to safety and Good Manufacturing Practices (GMP), with a focus on continuous improvement and effective quality oversight.

Requirements

• High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associate's degree with 8 years of experience OR a Bachelor's with at least 5 years of experience OR Master's Degree with more than 3 years of experience OR a PhD with 0+ years of experience.
• Experience in manufacturing, quality in the biotech or pharmaceutical industry.
• Previous management experience.
• Working knowledge in a biopharmaceutical/pharmaceutical cGMP environment.
• Knowledge of electronic systems such as Veeva, Trackwise, Documentum/PDOCs, SAP, LIMS, Microsoft Office.

Nice To Haves

• Master's degree and relevant pharmaceutical experience.
• Experience authoring, reviewing, etc. of procedures or training materials.
• Experience with aseptic practices, investigations, manufacturing support and batch release activities.
• Preferred experience with leading a team.

Responsibilities

• Recruit, onboard, train and develop colleagues under supervision.
• Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures, Regulatory requirements, Safety, Quality Agreement requirements, and Pfizer Quality Standards (PQS).
• Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues.
• Lead & identify Continuous Improvements (CI) initiatives to improve safety and processes.
• Represent QA in cross-departmental/cross-site meetings and aid in resolving issues.
• Independently make decisions with minimal assistance from QA management and escalate issues timely.
• Provide guidance/coaching/training to less experienced QA and Manufacturing colleagues.
• Participate in internal Good Manufacturing Practices (cGMP) audits and support regulatory inspections or corporate audit activities.
• Assist with Internal Audits/Assessments, Gap/risk assessments, and Regulatory Inspection Readiness.
• Manage own time to meet objectives, plan of record deliverables, and project milestones.
• Support the development of quality strategic initiatives based on risk and business needs.
• Ensure real-time review of batch documentation and other manufacturing documentation for compliance.
• Monitor and perform housekeeping and GMP walkthroughs of the facility.
• Triage events and initiate deviations as needed.
• Assist with driving effective management of quality issues and corrective action plans.
• Provide quality leadership to cross-functional teams to meet and exceed timelines.
• Execute or review room and line clearances.

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Paid vacation, holiday and personal days
• Paid caregiver/parental and medical leave
• Health benefits including medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: High school or GED