Senior QA Leader—GLP/GCP Compliance & Audits

Kelly Science, Engineering, Technology & Telecom; Philadelphia (Philadelphia County); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

PTO & holidays

401K

Job summary

Kelly Science and Clinical seeks a Senior Manager of Quality Assurance in the Greater Philadelphia area. The role oversees QA leadership, ensuring GLP/GLP/GCP compliance and 21 CFR Part 11 alignment. You will guide audits, CAPA, and regulatory inspections to support a leading pharmaceutical client.

We value deep regulatory knowledge, 10+ years in QA within clinical research, and strong leadership. The position includes standard benefits and a direct-hire path in a dynamic, collaborative

Qualifications

• B.S. degree in Life Sciences, Chemistry, Biology, Pharmaceutical Sciences, or related field; advanced degree preferred.
• 10+ years of progressive quality assurance in clinical research with CRO experience preferred.
• Strong knowledge of GLP (FDA, EPA & OECD), GCP, and 21 CFR Part 11 (ERES).
• 5+ years managerial or supervisory experience in a regulated Quality environment.
• Proven leadership with strong organizational and team-building skills.
• Excellent verbal and written communication skills.
• Strong knowledge of pharmaceutical/biotech and agrochemical industries.

Responsibilities

• Leads QA team and ensures compliance with GLP, GCP, and Part 11 requirements.
• Conducts risk-based audits of quality systems, studies, facilities, data, and records.
• Reviews SOPs and quality systems for adequacy and completeness; facilitates CAPA resolution.
• Hosts client audits and regulatory inspections when needed.
• Trains, mentors, and coaches QA staff; contributes to SOP development.

Skills

Leadership

Communication

Regulatory knowledge

Education

B.S. degree in Life Sciences/related

Advanced degree preferred

Job description

Kelly Science and Clinical seeks a Senior Manager of Quality Assurance in the Greater Philadelphia area. The role oversees QA leadership, ensuring GLP/GLP/GCP compliance and 21 CFR Part 11 alignment. You will guide audits, CAPA, and regulatory inspections to support a leading pharmaceutical client.

We value deep regulatory knowledge, 10+ years in QA within clinical research, and strong leadership. The position includes standard benefits and a direct-hire path in a dynamic, collaborative