2027 Summer Intern - External Quality (PTQX)

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, as well 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, and 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.

Program Highlights

• Intensive 12 months, full-time (40 hours per week) paid internship.
• Program start dates are in June (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 (not currently enrolled in a graduate program).
• Must have attained a Master's Degree.
• Must have attained a PhD.

Required Majors: Biochemistry, Biochemical Engineering, Biology, Chemistry, Pharmaceutical Sciences, Engineering.

Required Skills

• Sound 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.
• 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.
• Additional language skills are a plus.
• Operational Excellence expertise is 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.

Pay and benefits

The expected salary range for this position based on the primary location of California is $28.00-$47.00 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.

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.