GxP External Quality Intern — 12‑Month, Onsite SSF

Regulatory Jobs

South San Francisco (CA)

On-site

USD 39,000 - 65,000

Full time

2 days ago
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Job summary

Genentech is seeking a Summer Intern for External Quality (PTQX) in South San Francisco. The role focuses on quality and compliance oversight for external GxP suppliers, supporting audits, CAPAs and regulatory interactions.

The internship runs 12 months, full-time (40 hours/week) starting in June. A location-based stipend helps offset costs; relocation benefits are not available. English fluency is required.

Qualifications

  • Must have Bachelor's, Master's or PhD.
  • Majors include Biochemistry, Biochemical Engineering, Biology, Chemistry, Pharmaceutical Sciences, Engineering.
  • Fluency in oral and written English is required.
  • Sound knowledge of cGMP, ISO standards and international pharma regulations.

Responsibilities

  • Provide quality and compliance oversight for external GxP suppliers (CMO, CLO, direct material suppliers).
  • Serve as the Quality Point of Contact for designated suppliers and support supplier lifecycle activities.
  • Oversee lifecycle quality activities including audits, investigations, CAPAs, deviations and regulatory submissions.
  • Develop, negotiate and maintain risk-based Quality Agreements with GxP suppliers.

Skills

cGMP standards
GxP interpretation
MS Office / Google Suite
English fluency

Education

Bachelor's Degree
Master's Degree
PhD

Tools

MS Office
Google Suite
MS Project

Job description

Genentech is seeking a Summer Intern for External Quality (PTQX) in South San Francisco. The role focuses on quality and compliance oversight for external GxP suppliers, supporting audits, CAPAs and regulatory interactions.

The internship runs 12 months, full-time (40 hours/week) starting in June. A location-based stipend helps offset costs; relocation benefits are not available. English fluency is required.

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