QA Manager, Manufacturing Quality Assurance

Use Your Power for Purpose

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.

What You Will Achieve

The Manufacturing Support Quality Operations Lead is responsible for operational management and leadership of quality teams in support of manufacture testing and release of Monoclonal Antibodies and Vaccines drug substance and drug substance intermediate products. The manufacturing support quality lead will be responsible for leading and managing a suite of functions that support production operations across the Sanford facility. The primary role is to ensure that activities are conducted in compliance with current GMP regulatory requirements quality agreement requirements safety and Pfizer expectations. They will provide guidance to site operational teams as well as assuring the optimal organization of resources to support timely delivery of commitments. The Manufacturing Support Quality Lead not only leads the team but also takes part in the execution of related functions. The incumbent works cross functionally with manufacturing support groups to ensure prompt resolution of issues and on time delivery. This leader supports site internal and external regulatory inspections. This role is based at the Pfizer Sanford NC Pfizer Global Supply (PGS) site and provides on-call after hours and weekend quality support as needed.

In this role you will:

• Recruit onboard train and develop colleagues under his supervision.

• Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures Regulatory requirements Safety Quality Agreement requirements and Pfizer Quality Standards (PQS) expectations.

• Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues on a regular basis.

• Lead & identify Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the one best way philosophy.

• Represent QA in cross-departmental/cross-site meetings. Aid in resolving and provide guidance/path-forward. Independently makes decisions with minimal assistance from QA management. Escalate issues timely.

• Provide guidance/coaching/training to less experienced QA and Manufacturing colleagues. Participate in internal Good Manufacturing Practices also cGMP audits support regulatory inspections or corporate audit activities.

• 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 in close collaboration with key stakeholders.

• Monitor and Perform housekeeping and GMP walkthroughs of facility.

• Triage events and initiate deviations as needed. Assist with driving effective management of quality issues and corrective action plans that may involve complex quality and technical issues.

• Provide quality leadership to cross functional teams to meet and exceed timelines.

• Makes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal procedures.

• Acts as designee for site quality operations lead as required.

• Review/approve new/existing procedures (SOPs MBRs Job Aids etc.) in Documentum/ PDOCS to ensure proposed critical changes to procedures and/or processes are completed/documented appropriately.

• Assist with other tasks as needed such as: Lot Release Protocol creation and submission Internal Audits/Assessments FDA response coordination Gap Analysis Regulatory Inspection Readiness Site metric reporting work order approvals facility environmental monitoring and microbial control manufacturing area shutdown and new product introductions.

Here Is What You Need(Minimum Requirements)

• Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience

• Experience in manufacturing quality or engineering in the biotech or pharmaceutical industry.

• Knowledge of the principles and concepts of current Good Manufacturing Practices (cGMPs) used in the Pharmaceutical Industry.

• Knowledge of and experience in a biopharmaceutical/pharmaceutical cGMP environment. Collaboration skills and the ability to independently engage with a wide range of co-workers customers and management to gather the input and background knowledge needed to complete assignments.

• Experience with aseptic practices investigations manufacturing support and batch release activities.

• Knowledge of cGMPs electronic systems (Veeva Trackwise Documentum SAP gLIMS Microsoft Office).

Bonus Points If You Have(Preferred Requirements)

• Effective written and verbal communication skills coupled with interpersonal skills and the ability to establish relationships within the company.

• Strong attention to detail.

• Proactively identifies takes remedial action and/or seeks advice when a personal project or team goal/deliverable timeline is at risk.

• Ability to positively receive feedback from management and colleagues.

• Takes accountability for actions and personal development.

• Ability to organize work tasks and adhere to assigned work to meet deadlines and departmental goals.

• Preferred experience with managing and leading a team

• Effectively manages stressful situations able to focus on task at regardless of circumstances and stress induced pressure.

Physical or Mental Requirements:

• Requires working on shop floor and office setting.

• Aseptic Gowning into manufacturing areas.

• Computer usage would be typical.

• Remaining in a controlled environment for more than three (3) hours.

• Ability to stand for 2 to 3 hours at a time.

• Evaluate complex mathematical calculations.Walk long distances

Non-Standard Work Schedule:

Work schedule is primarily first shift during weekdays but may include weekends and second and/or third shift hours to supply needs. Ability to adhere to safe work practices and procedures such as aseptic gowning. Limited travel for the position no more than 5% traveling.

Work Location Assignment:On Premise

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