New · posted Nov 5
Genentech · Biotechnology
2027 Summer Intern - External Quality
- South San Francisco, CA
- On-site
- Internship
- Associate & Specialist
The role
Department Summary
External Quality is responsible for the Quality and Compliance of externally sourced raw materials, supply from CDMOs, and distribution quality from Roche sites to Affiliates, including the certification for the EU market. We serve our patients through external partnerships because access to quality products is every patient’s right, as well we leverage external partners to offer flexibility to our internal capacity at the correct cost and quality, we enable our external partners to reliably deliver compliant, quality products to our supply chain customers so that we can deliver to patients worldwide, and do this through cross-functional collaborations, ensuring quality process excellence and continuous improvement.
This internship position is located in South San Francisco, on-site
- Provide quality and compliance oversight for external GxP suppliers, including CMO, CLO, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems, and service providers to ensure compliance with cGMP and Quality Agreement requirements.
- Serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of GxP supplier cross-functional management teams to enable (as applicable for the supplier lifecycle stage) site selection and implementation (including due diligence activities), ongoing quality supply of commercial products, materials or services from suppliers, and decommissioning.
- Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage, and Decommission), including but not limited to: process or method validations, Roche and Health Authority audits, complex investigations, market complaints, and regulatory submissions.
- Develop, negotiate and maintain risk-based Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers and ensure compliance with agreements.
- Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regard to quality and time with the supplier; and escalate as appropriate.
Program Highlights
- Intensive 12 months, full-time (40 hours per week) paid internship.
- Program start dates are in June (Summer).
- A stipend, based on location, will be provided to help alleviate costs associated with the internship.
- Ownership of challenging and impactful business-critical projects.
- Work with some of the most talented people in the biotechnology industry.
What you need
Required Skills
- Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals.
- Ability to interpret quality standards as they relate to GxP suppliers.
- Highly competent in MS Office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.
- Fluency in oral and written English is a must.
You meet one of the following criteria
- Must have attained a Bachelor's Degree (not currently enrolled in a graduate program).
- Must have attained a Master's Degree.
- Must have attained a PhD.
Preferred Knowledge, Skills, and Qualificationsnice to have
- Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus.
- Experience with GxP suppliers such as CMO, CLO, and direct material suppliers is a plus.
- Additional language skills are a plus.
- Operational Excellence expertise is a plus.
- Excellent communication, collaboration, and interpersonal skills.
- Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion.
Relocation benefits are not available for this job posting.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
Pay and benefits
$58,240 – $97,760 a year
Employer provided$28.00 – $47.00 an hour · yearly at 2,080 hours (40 a week)
How this comparesThe expected salary range for this position based on the primary location of California is $28.00-$47.00 per hour. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. This position also qualifies for paid holiday time off benefits.
Paid internship
Stipend based on location
Paid holiday time off
Where you'll work
South San Francisco, CAOn-siteOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAWorking conditions
Required Majors: Biochemistry, Biochemical Engineering, Biology, Chemistry, Pharmaceutical Sciences, Engineering.
Equal opportunity, accessibility and legal noticesGenentech's statements, word for word
Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 37% above the US median for Supplier Quality roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US13 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $58,240 | — | $97,760 |
| All US (middle half) | $53,000 | $57,000 | $78,000 |
This role: Genentech's own published range, converted to a year at 2,080 hours. Comparisons: the base pay employers published on open Supplier Quality roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Supplier Quality
The general path across 80 open Supplier Quality roles on Regulatory Jobs, with the titles they carry most. Not Genentech's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 27 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance9
- Quality systems and risk8
- Collaboration and leadership4
- Lab testing and methods2
- Investigations and CAPA2
- Validation and qualification2
- Regulatory submissions1
- Data and digital systems1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Supplier Quality work in biotechnology, led by the two this posting names, each linked to the agency or standards body that publishes it.
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality AgreementsNamed in the posting
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticalsNamed in the posting
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- EUEU Good Distribution Practice(official source, opens in a new tab)Guidelines on good distribution practice of medicinal products for human use
- FDADrug Supply Chain Security Act(official source, opens in a new tab)Product tracing, verification and serialization across the US drug supply chain
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- USPUSP–NF(official source, opens in a new tab)US Pharmacopeia general chapters and monographs, such as <61> bioburden, <85> endotoxin, <1225> validation
- EDQMEuropean Pharmacopoeia(official source, opens in a new tab)The Ph. Eur. quality standards for medicines in Europe, published by the EDQM
- FDA21 CFR Parts 600 to 680(official source, opens in a new tab)FDA standards for biological products, from licensing to lot release
Company hiring pulse
Genentech on Regulatory Jobs
- 27
- Open roles
- 26
- Distinct roles
- 6
- Locations
By discipline
- Quality16 59%
- Regulatory7 26%
- Clinical4 15%
By level
- Senior & Principal19 70%
- Director3 11%
- VP & Executive2 7%
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2027 Summer Intern - External Quality at Genentech
Applications close November 18. $58K–$98K a year, employer provided.