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.
Are you a self-starter who is passionate about continuous improvement? Do you enjoy learning and collaborating globally, and making a direct impact on serving patients? If yes, the GxP Supplier Quality Manager might be the right challenge for you.
We serve our patients through external partnerships because access to quality products is every patient's right. Our team leverages external partners 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 achieve this through cross-functional collaborations, ensuring quality process excellence and continuous improvement.
The GxP Supplier Quality Manager position provides quality and compliance oversight for external GxP suppliers, including Contract Manufacturing Organizations (CMO), Contract Laboratory Organizations (CLO), suppliers/distributors of direct materials or critical process-contacting spare parts, and service providers. This role ensures compliance with cGMP and quality agreement requirements. You will serve as the Quality Point of Contact (PoC) for designated suppliers and participate as a key member of cross-functional management teams throughout the entire supplier lifecycle (site selection, ongoing supply, and decommissioning).
Here are the key responsibilities you'll handle in this role:
Oversee all required quality activities during the GxP supplier lifecycle, including process/method validations, audits, complex investigations, market complaints, and regulatory submissions.
Develop, negotiate, and maintain risk-based Quality Agreements and Product Specific Requirements with GxP suppliers and ensure compliance with these agreements.
Collaborate with suppliers to resolve gaps in audit responsiveness, CAPA implementation, deviation reporting/management, complaint management, investigation closure, and change implementation.
Develop and maintain quality risk management plans, utilizing risk management tools to identify and mitigate quality/compliance risks and ensure suppliers are inspection-ready.
Support or lead supplier improvement initiatives to solve complex manufacturing or quality problems, and identify, design, and implement process and system improvements.
Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations align with Roche objectives.
Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance, and troubleshoot/drive the resolution of quality issues.
You'll be a great fit if you meet these qualifications:
You possess a B.A. or B.S. degree in life sciences or equivalent and have experience in the pharmaceutical or a related industry (experience with quality management of GxP service providers is a plus).
You have a sound knowledge of cGMP, ISO standards, and international regulations for pharmaceuticals, with the ability to interpret quality standards as they relate to GxP suppliers.
You are proficient in both written and verbal English (additional language skills are a plus) and can communicate clearly and professionally.
You have a proven ability to influence across cultures and functional reporting lines, to drive continuous improvement initiatives, and demonstrate an agile mindset and behavior.
You are highly competent in MS office or Google Suite applications (including Excel, Powerpoint, Word, and MS Project, etc.).
Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!
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.