2026 Summer Internship - External Quality at Genentech

Daly City, California, United States -

Full Time

Start Date

Immediate

Expiry Date

06 Mar, 26

Salary

46.0

Posted On

06 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Knowledge Of Cgmp, Iso Standards, International Regulations, Quality Standards, Ms Office, Google Suite, Communication Skills, Fluency In English

Industry

Biotechnology Research

Description

The Position 2026 Summer Internship - External Quality 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. 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. The Opportunity 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. Program Highlights 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. Who You Are (Required) 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. Preferred Knowledge, Skills, and Qualifications: 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. Relocation benefits are not available for this job posting. The expected salary range for this position based on the primary location of South San Francisco is $33.00-$46.00 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. 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. 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.

Responsibilities

Provide quality and compliance oversight for external GxP suppliers and serve as the Quality Point of Contact for designated suppliers. Oversee all required quality activities during the lifecycle of a GxP supplier, including audits, investigations, and regulatory submissions.