2027 Summer Intern - External Quality (PTQX)

Genentech•Daly City, CA

5d•$28 - $47•Onsite

About The Position

This 2027 Summer Intern position is part of External Quality, which is responsible for quality and compliance related to externally sourced raw materials, supply from contract development and manufacturing organizations (CDMOs), and distribution quality from Roche sites to affiliates, including certification for the EU market. The team works with external partners to support patient access to quality products, provide flexibility in internal capacity, and enable reliable delivery of compliant products through cross-functional collaboration, quality process excellence, and continuous improvement. The intern will provide quality and compliance oversight for external GxP suppliers, including manufacturers, laboratories, suppliers of direct materials or critical process-contacting spare parts, suppliers of analytical equipment or manufacturing systems, and service providers. The role serves as the Quality Point of Contact for designated suppliers and participates in cross-functional supplier management teams. It supports supplier lifecycle activities, including selection, implementation, ongoing supply, and decommissioning, as well as quality activities such as validations, audits, investigations, complaints, and regulatory submissions. The position also involves developing and maintaining risk-based Quality Agreements and Product Specific Requirements, monitoring compliance, and collaborating with suppliers to address quality and timeliness gaps. The internship is a paid, full-time program lasting 12 months and requiring 40 hours per week. It is based on-site in South San Francisco, with a June 2027 program start. A location-based stipend is provided to help with internship costs. The position offers ownership of challenging, business-critical projects and the opportunity to work with biotechnology industry professionals. Relocation benefits are not available.

Requirements

Must have attained a Bachelor's degree and not currently be enrolled in a graduate program, or have attained a Master's degree or PhD.
Degree major must be in Biochemistry, Biochemical Engineering, Biology, Chemistry, Pharmaceutical Sciences, or Engineering.
Sound knowledge of cGMP, ISO standards, and international regulations for pharmaceuticals.
Ability to interpret quality standards as they relate to GxP suppliers.
High competency with MS Office or Google Suite applications, including Excel, PowerPoint, Word, and MS Project.
Fluency in oral and written English.

Nice To Haves

Previous experience in the pharmaceutical or related industry, or an equivalent combination of education and experience.
Experience with GxP suppliers such as CMO, CLO, and direct material suppliers.
Additional language skills.
Operational Excellence expertise.
Excellent communication, collaboration, and interpersonal skills.
Alignment with the company’s values and behavioral standards of Integrity, Courage, and Passion.

Responsibilities

Provide quality and compliance oversight for external GxP suppliers to ensure compliance with cGMP and Quality Agreement requirements.
Serve as the Quality Point of Contact for designated suppliers and participate in cross-functional GxP supplier management teams.
Support supplier site selection and implementation, including due diligence, ongoing quality supply, and decommissioning.
Oversee quality activities across the supplier lifecycle, including 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 with GxP suppliers, and ensure compliance with them.
Collaborate with suppliers to address gaps in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation.
Escalate supplier quality issues as appropriate.