At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.

The Position

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love.

Thats what makes us Roche.

At Roche we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision. We serve our patients through external partnerships because access to quality products is every patients right. We leverage external partners in order to offer flexibility to our internal capacity at the right 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.

The Opportunity:

• Provide quality and compliance oversight of external GMP suppliers including CDMOs CROs/PET centers CLOs and in-licensing partners to ensure compliance with cGMP and quality agreement requirements.

• Serve as the Quality Point of Contact for these GMP suppliers and participate as a key member of cross-functional management teams to enable GMP supplier site selection qualification and implementation management and decommissioning

• Oversee and execute all required quality activities during the lifecycle of a GMP supplier including but not limited to:

• • Negotiation and maintenance of Quality Agreements and associated documents

  • Monitoring cGMP compliance and reporting quality performance identifying and mitigating quality risks

  • Supporting Roche audits ensuring audit responsiveness and CAPA implementation

  • Tech transfers and process validation and Inspection readiness for commercial CMOs as applicable

• Execute all required activities to support Make Assess and Release commercial and investigational medicinal products including but not limited to risk assessments approval of method validation master batch records and executed records complex investigations and changes. Ensure project milestones as well as expectations such as on time closure are met.

• Serve as Quality Point of Contact to the technical development team and provide end-to-end quality oversight. Execute the Product Specification File (PSF) intra-company agreements approve the control system review CMC sections of Health Authority submissions and related activities.

• Perform disposition of outsourced investigational medicinal products in SAP including API and Drug Product of Synthetic Molecules and Biologics

Who you are:

• B.S. . or PhD in life sciences or equivalent with at least 8 years Manufacturing and/or Quality experience with Synthetic Molecules including Steriles in the pharmaceutical or related GMP industry. Experience with siRNA (oligos/peptides) and Biologics is a plus.

• The ideal candidate has GMP QA experience of bulk API and Drug Product clinical supply operations including release.

• Sound knowledge of cGMP ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GMP products.

• Excellent Quality decision making skills in complex environments

• Proven ability to influence across cultures and functional reporting lines and to drive continuous improvement initiatives

• Ability to operate in a self-managed way of working with a key focus on collaboration agility and innovation mindset

• Ability to work in a purpose driven organization taking full ownership for assigned roles and tasks continuously willing to improve individual and team effectiveness

This position may require up to 10% domestic and/or international travel

** Relocation benefits not available for this position**

Who we are

A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.

Lets build a healthier future together.