GxP Supplier Quality Manager

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.

At Roche where structure innovation and patient safety converge we are committed to delivering high-quality healthcare solutions worldwide.

As a GxP Supplier Quality Manager you will play a pivotal role in maintaining the integrity of our global supply chain across the entire lifecycle of GxP suppliers (Source & Select Implement Manage and Decommission). You will serve as a primary quality key contact for Contract Manufacturing Organizations (CMOs) and Contract Laboratory Organizations (CLOs)

ensuring that external partnerships align with Roches high quality standards and regulatory commitments.

Key Responsibilities & Main Tasks

• GxP Supplier Lifecycle Management: Oversee all required quality activities across the full lifecycle of assigned GxP suppliers (Source & Select Implement Manage and Decommission) including process or method validations Roche audits Health Authority inspections complex investigations product complaints and regulatory submissions.
• Quality Agreements: Develop negotiate and maintain Quality Agreements with GxP suppliers Partners Collaborators and External Sponsors ensuring continuous compliance with agreed terms and regulations.
• Supplier Collaboration & Escalation: Collaborate with GxP suppliers to address gaps in audit responsiveness deviation reporting/management CAPA implementation complaint resolution investigation closures and change control timelines; escalate quality or compliance risks appropriately.
• Support Make Assess: Manage all required quality deliverables supporting the Make Assess phase of Roche products including approval of master process documentation batch documentation review resolution of complex deviations change assessment and ongoing supplier quality performance monitoring.
• Validated State & Compliance Maintenance: Ensure manufacturing and QC processes (including Specifications Analytical Methods and stability testing programs) remain in a validated state and fully compliant with applicable regulatory dossiers.
• Quality Risk Management (QRM): Develop and maintain quality risk management plans using established QRM tools (e.g. FMEA root cause analysis) to proactively identify mitigate and monitor supplier quality and compliance risks.
• Technical Transfers & Product Launches: Lead and execute quality deliverables supporting technical transfers for manufacturing testing packaging and commercial product launches at external sites.
• Continuous Improvement & Operational Excellence: Engage in cross-functional continuous improvement initiatives to solve complex manufacturing or quality challenges while driving alignment between supplier operations and Roche strategic goals.
• Regulatory Landscape & Intelligence: Communicate updated regulatory requirements and Roche expectations to GxP suppliers evaluating site quality systems for ongoing compliance.

Who You Are

You are a self-motivated Quality professional who thrives in a dynamic matrixed environment. You bring strong critical thinking proactive communication and the ability to influence external partners while keeping patient safety at the center of every decision.

Qualifications & Experience:

• Education: Ideally a B.A. or B.S. degree in Life Sciences Chemistry Pharmacy Engineering or a related discipline (or equivalent combination of education and industry experience).
• Experience: Minimum of 35 years of progressive experience in the pharmaceutical or biotech industry in Quality Assurance Quality Control or Supplier Quality Management.
• GxP & Supplier Expertise: Demonstrated experience with GxP supplier oversight (e.g. CMOs CLOs direct material suppliers) and familiarity with different technology platforms/dosage forms is preferred.
• Regulatory Knowledge: Sound knowledge of cGMP ISO standards and international pharmaceutical regulations (e.g. FDA EMA ICH Q9/Q10/Q12).
• Influence & Stakeholder Management: Strong capability to interpret complex quality standards drive accountability with external vendors without direct authority and negotiate Quality Agreements.
• Technical Skills: Operational Excellence (Lean/Six Sigma) and Project Management experience are a plus. High proficiency in MS Office or Google Workspace applications (Excel PowerPoint Word Project).
• Languages & Travel: Excellent written and verbal communication skills in English (fluency is required). Ability to travel domestically and/or internationally up to 10%.

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.

Roche is an Equal Opportunity Employer.