2026 Summer Internship - External Quality

Roche•South San Francisco, CA

21d•$33 - $46•Onsite

About The Position

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. 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. We 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. 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. Intensive 12 months, full-time (40 hours per week) paid internship. Program start dates are in June 2026 (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.

Requirements

Required Education - You meet one of the following criteria:
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.
Required Skills: 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.

Nice To Haves

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.

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.