Senior QA Manager, Pharma – Regulatory & Audit Leader

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

Benefits offered by this job

Medical benefits

Paid time off

Vacation

Holidays

401K

Job summary

Kelly Science and Clinical is seeking a Sr Manager of Quality Assurance for a top pharmaceutical client in the Greater Philadelphia area. This direct-hire role leads a QA team and ensures compliance with GLP, GCP, and 21 CFR Part 11, while driving continuous quality improvements.

The ideal candidate has a BS in Life Sciences and 10+ years in clinical QA with CRO experience, plus at least 5 years of managerial experience. Competitive benefits are offered, with PTO and 401K included.

Qualifications

• BS 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, 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.

Responsibilities

• Applies strong understanding of GLP, GCP and 21 CFR Part 11 to QA work.
• Leads QA team and promotes quality improvement culture.
• Leads risk-based audits of quality systems and study processes.
• Reviews SOPs and quality systems for compliance and adequacy.
• Hosts client audits and regulatory inspections as needed.
• Trains and mentors QA staff and develops SOPs.

Job description

Kelly Science and Clinical is seeking a Sr Manager of Quality Assurance for a top pharmaceutical client in the Greater Philadelphia area. This direct-hire role leads a QA team and ensures compliance with GLP, GCP, and 21 CFR Part 11, while driving continuous quality improvements.

The ideal candidate has a BS in Life Sciences and 10+ years in clinical QA with CRO experience, plus at least 5 years of managerial experience. Competitive benefits are offered, with PTO and 401K included.