Quality & Compliance SME

Job Title:
Senior GMP Quality Systems & Compliance SME

Location: Philadelphia, PA (Hybrid Schedule)

Description:

We are seeking an experienced Senior GMP Quality Systems & Compliance Subject Matter Expert (SME) to support pharmaceutical manufacturing operations at a leading biopharmaceutical facility in Philadelphia, PA. This contract opportunity requires a strong background in GMP quality systems, regulatory compliance, and operational excellence within a pharmaceutical manufacturing environment.

The successful candidate will provide strategic and hands‑on expertise across quality systems, manufacturing compliance, and operational quality initiatives to ensure adherence to FDA, EMA, and global regulatory requirements.

• Serve as the SME for GMP Quality Systems, Compliance, and Quality Operations.
• Lead and support Quality Culture initiatives to drive continuous improvement and compliance excellence.
• Provide expertise in CAPA management, Change Control, Deviation Management, and Quality Risk Management processes.
• Support Data Integrity programs, Record Retention strategies, Process Performance Monitoring, and Product Quality Reviews.
• Collaborate with Manufacturing, Quality Assurance, Quality Control, Engineering, and Supply Chain teams to ensure GMP compliance.
• Provide oversight and guidance for Vendor Management and GMP Training programs.
• Support compliance activities related to Materials Management, Warehouse Operations, Gowning Programs, Access Control Systems, and Environmental Health & Safety (EHS).
• Assess and strengthen quality systems to ensure inspection readiness and sustainable compliance.
• Identify compliance gaps, recommend corrective actions, and implement process improvements.
• Support internal audits, regulatory inspections, and remediation activities as required.

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or a related discipline.
• Extensive experience in pharmaceutical, biotechnology, or biologics manufacturing environments.
• Strong expertise in GMP Quality Systems, Compliance, and Regulatory Requirements.
• Proven experience with CAPA, Change Control, Deviations, Data Integrity, Vendor Management, and Quality Culture programs.
• Working knowledge of FDA, EMA, ICH, and global GMP regulations.
• Demonstrated ability to lead cross-functional compliance and quality improvement initiatives.
• Excellent communication, stakeholder management, and problem‑solving skills.