Senior QA Leader - GLP/GCP Compliance

Kelly Services

Malvern (Chester County)

On-site

USD 110,000 - 120,000

Full time

33 hours ago
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Benefits offered by this job

Medical benefits
Paid time off (PTO)
Holidays
401K
Transit spending account
Paid sick leave

Job summary

Kelly Science & Clinical is seeking a Sr Manager, Quality Assurance for our pharmaceutical client in Chester County, PA. Lead the Malvern QA team, ensuring GLP, GCP, and 21 CFR Part 11 compliance, and driving quality improvements across audits and investigations.

You will coach staff, host client inspections, and partner with cross‑functional teams to sustain a culture of quality. The role offers competitive compensation, benefits, and a direct hire arrangement in a dynamic science environment.

Qualifications

  • BS degree in Life Sciences, Chemistry, Biology, or related field.
  • 10+ years of progressive quality assurance in clinical research; CRO experience preferred.
  • Strong knowledge of GLP, GCP, and 21 CFR Part 11 (ERES).

Responsibilities

  • Lead QA team and promote quality improvement culture.
  • Audit quality systems and ensure regulatory compliance.
  • Review SOPs and facilitate CAPA investigations.
  • Host client audits and regulatory inspections as needed.
  • Train, mentor, and develop QA staff.
  • Provide quality guidance to personnel and ensure documentation integrity.

Skills

Leadership
QA Management
GLP/GCP Knowledge
21 CFR Part 11
Regulatory Compliance

Education

BS in Life Sciences or related field
Advanced degree preferred

Job description

Kelly Science & Clinical is seeking a Sr Manager, Quality Assurance for our pharmaceutical client in Chester County, PA. Lead the Malvern QA team, ensuring GLP, GCP, and 21 CFR Part 11 compliance, and driving quality improvements across audits and investigations.

You will coach staff, host client inspections, and partner with cross‑functional teams to sustain a culture of quality. The role offers competitive compensation, benefits, and a direct hire arrangement in a dynamic science environment.

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