Senior QA Leader – GLP/GCP Compliance

Kelly Services; Malvern (Chester County); On-site; USD 110,000 - 120,000; Full time

Benefits offered by this job

Medical benefits

PTO & holidays

401K

Job summary

Kelly Science & Clinical is seeking a Sr Manager, Quality Assurance for an engagement in the Greater Philadelphia area. The role oversees QA activities to ensure GLP, GCP, and 21 CFR Part 11 compliance, leading a team and coordinating audits. Competitive benefits and direct hire opportunity.

Location: Greater Philadelphia, PA. Mon-Fri 8AM-5PM; salary $110,000-$120,000 with 401K, PTO, and medical benefits.

Qualifications

• BS degree in Life Sciences or related field; advanced degree preferred.
• 10+ years of progressive QA in clinical research; CRO experience preferred.
• Strong knowledge of GLP, GCP, and 21 CFR Part 11.
• 5+ years of managerial or supervisory experience in a regulated QA environment.
• Excellent verbal and written communication; leadership and team-building skills.

Responsibilities

• Applies strong understanding of GLP, GCP and 21 CFR Part 11 regulations to QA work.
• Leads QA team and promotes a culture of quality and collaboration.
• Leads risk-based audits of quality systems, study processes, and data.
• Reviews SOPs and quality systems for compliance; facilitates CAPA resolution.
• Hosts client audits and regulatory inspections as needed.
• Trains, mentors, and coaches QA staff; develops SOPs and training.
• Develops and measures quality metrics for GCP/GLP activities.
• Reviews/approves quality documentation per SOPs and regulatory requirements.

Skills

GLP/GCP knowledge

Regulatory compliance

Leadership

Communication skills

Quality systems

Education

B.S. Life Sciences or related

Advanced degree preferred

Job description

Kelly Science & Clinical is seeking a Sr Manager, Quality Assurance for an engagement in the Greater Philadelphia area. The role oversees QA activities to ensure GLP, GCP, and 21 CFR Part 11 compliance, leading a team and coordinating audits. Competitive benefits and direct hire opportunity.

Location: Greater Philadelphia, PA. Mon-Fri 8AM-5PM; salary $110,000-$120,000 with 401K, PTO, and medical benefits.