Genentech ยท 5 hours ago
2026 Summer Internship - External Quality
South San Francisco, CA
Internship
Onsite
Intern
$33/hr - $46/hr
Start in 2026 SummerGenentech is a leading biotechnology company specializing in quality and compliance for externally sourced materials. They are seeking a 2026 Summer Intern in External Quality to provide oversight for GxP suppliers, ensuring compliance with regulations and quality standards while collaborating with cross-functional teams.
BiotechnologyLife ScienceManufacturing
Responsibilities
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
As applicable, manage all required activities to support Make Assess Release (MAR) of commercial medicinal products including approval of master process documentation, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance
As applicable, release, reject or quarantine commercial medicinal products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Swissmedic and Roche requirements on behalf of the Responsible Person (RP)
As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs
As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of continuous inspection readiness
As applicable, manage or lead technical transfers for manufacturing, testing, packaging, and product launches
As applicable, support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify, design and implement process and system improvements
Qualification
Required
Must have attained a Bachelor's degree (recent graduates not currently enrolled in a grad program)
Have attained a Master's Degree
Have attained a PhD
Required Majors: Biotechnology, Bioengineering, Chemistry, Biochemistry, Biology or related
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
Ability to communicate clearly and professionally both in writing and verbally
Fluency in oral and written English is a must
Preferred
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
Operational Excellence expertise is a plus
Additional language skills are a plus
Excellent communication, collaboration, and interpersonal skills
Complements our culture and the standards that guide our daily behavior & decisions: Integrity, Courage, and Passion
Benefits
Paid holiday time off benefits
Company
Genentech
Genentech is a biotechnology research company that specializes in genetic testing and personalized medicines.
Founded in 1976
10001+ employees
H1B Sponsorship
Genentech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (133)
2024 (148)
2023 (150)
2022 (178)
2021 (121)
2020 (158)
Funding
Current Stage
Public CompanyTotal Funding
unknown2009-03-26Acquired
1999-07-20IPO
1976-01-01Series Unknown
Leadership Team
Ashley Magargee
CEO
Michael Laird
Vice President
Recent News
2025-12-30
Pharmaceutical Technology
2025-12-29
Pharmaceutical Technology
2025-12-24
Company data provided by crunchbase