2027 Summer Intern - External Quality (PTQX)

Roche•South San Francisco, CA

5d•$28 - $47•Onsite

About The Position

External Quality oversees the quality and compliance of externally sourced raw materials, supply from 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 to internal capacity, and enable partners to deliver compliant, quality products to supply chain customers through cross-functional collaboration, process excellence, and continuous improvement. This on-site internship is based in South San Francisco. The intern will provide quality and compliance oversight for external GxP suppliers, including manufacturers, laboratories, direct-material and critical spare-parts suppliers, suppliers of analytical equipment or manufacturing systems, distributors, and service providers. The role serves as a Quality Point of Contact for designated suppliers and participates in cross-functional supplier-management teams throughout supplier selection, implementation, ongoing supply, and decommissioning. The intern will oversee supplier lifecycle quality activities, including validations, audits, investigations, market complaints, and regulatory submissions. The role also develops, negotiates, and maintains risk-based Quality Agreements and Product Specific Requirements, and collaborates with suppliers to address issues involving audit responses, CAPAs, deviations, complaints, investigations, and change implementation. The program is a paid, full-time, 12-month internship requiring 40 hours per week, with a summer start date in June. A location-based stipend is provided to help with internship-related costs. Interns take ownership of challenging, business-critical projects and work with biotechnology industry professionals. Relocation benefits are not available. The expected California salary range is $28.00–$47.00 per hour, with paid holiday time off benefits.

Requirements

Must have attained a Bachelor's degree and not currently be enrolled in a graduate program, or must have attained a Master's degree or PhD.
Required majors: 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 competence with MS Office or Google Suite applications, including Excel, PowerPoint, Word, and MS Project.
Fluency in spoken and written English.
Excellent communication, collaboration, and interpersonal skills.
Ability to work on-site in South San Francisco.

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.
Alignment with the company’s stated values 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 required supplier lifecycle quality activities, 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 agreements.
Collaborate with suppliers to address gaps in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation; escalate as appropriate.