Quality Assurance Specialist

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. It’s 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.

That’s what makes us Roche.

The Position

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 patient’s 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 for external GxP suppliers including CDMOs, CRO/PET centers, CLOs and in-licensing partners to ensure compliance with cGMP and quality agreement requirements. You serve as the Quality Point of Contact for designated GxP suppliers and participate as a key member of cross-functional management teams to enable site selection, qualification and implementation, ongoing quality supply of commercial and investigational medicinal products, and decommissioning

Oversee all required quality activities during the lifecycle of a GxP supplier, including but not limited to the following:

• Negotiation and maintenance of Quality Agreements and Product Specific Requirements with GxP suppliers, ensuring compliance with agreements
• Monitoring and reporting GxP Supplier quality performance, identifying and mitigating quality risks
• Tech transfers and process validation as applicable
• Roche audits and Health Authority inspections, and regulatory submissions.
• Collaborate with GxP suppliers to address gaps of audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation, ensuring Key Performance Indicators are met
• Manage all required activities to support Make Assess Release of commercial or investigational medicinal products including approval of master process documentation, resolution of investigations, assessment of changes, and disposition.
  
  

Who you are:

• B.S., M.Sc. or PhD in life sciences or equivalent. Manufacturing and/or Quality experience with Synthetic Molecules, including peptides or RNA based, and/or Biologics in the pharmaceutical or related industry.
• The ideal candidate has GMP QA experience managing bulk clinical supply
• Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to GxP suppliers
• 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
• Ability to communicate clearly and professionally in English, both in writing and verbally
• This position may require up to 10% domestic and/or international travel
  
  

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 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.