Quality Product 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 Opportunity

This job description defines the roles and responsibilities of the Product Quality Specialist within Network Quality Operations. The PQS provides Quality support for late stage development products and the commercial product network and portfolio. The PQS serves as QSPOC of the TDT and owns targeted initiatives and Quality improvement activities upon request by product teams and PTx functions. The PQS works across the Quality network to support product team goals, strategies and deliverables related to Quality as requested by product team members.

• Provide support for product quality topics as requested by TDT, TPT, or commercial PTx colleagues, coordinating with site/functional Quality representatives as needed
• Oversee defined product-specific PQS deliverables including icQAG, PSF, RMT, and Quality Records in Veeva, as needed
• Support multisite investigations and provide change control support upon request
• Support due diligences for late-stage assets and/or commercial product divestments
• Provide QA/Compliance support for PPQ and PAI readiness, including risk/mitigation proposals to enable “filing go” decisions for significant transfers/major PAS submissions
• Work on strategic, global initiatives or multi-product activities to ensure alignment across the portfolio. Support in coordinating Quality activities for sites, TDTs, and/or TPTs
• Escalate identified risks and issues, support trending of drug-related complaints, and escalate adverse trends. Propose strategies for significant quality issues and risks to relevant leadership teams
  
  
  

Who You Are
The QPS role demands strong communication, collaboration, critical thinking, and decision-making skills, along with the ability to solve intricate problems.

• Graduate or higher-level degree in life sciences, chemistry, or a related scientific discipline with 10-12 years of progressive work experience in the pharmaceutical or related industry
• Demonstrated leadership experience in a GMP environment, including QA/QC, technical development, regulatory, or manufacturing areas
• Highly self-motivated, well-organized, solution-oriented, and continuously improving mindset with the ability to innovate when faced with challenges or opportunities
• Strong decision-making skills in complex environments, excellent written and verbal communication for presenting to diverse audiences, and solid understanding of new product modalities and development initiatives
• Strong negotiation and collaboration skills in a cross-functional matrix organization, with a demonstrated drive for results, initiative, and good organizational skills
• 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.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.