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.
Main Purpose of the Position
Provide quality and compliance oversight for assigned external GxP suppliers and outsourced products to ensure compliance with cGMP and Quality Agreement requirements. External GxP suppliers can include CDMOs, CLOs, CROs, CWO, partners, suppliers or distributors of direct materials or critical process-contacting spare parts, suppliers for analytical equipment or manufacturing systems and service providers.
Serve as the Quality Point of Contact (PoC) for designated suppliers and/or products and contribute as a key member of GxP supplier cross-functional management teams to select, implement, manage and decommission these suppliers as applicable to ensure quality of product supply and/or materials or services.
Provide quality expertise and compliance assessment for in-licensing and M&A due diligence events, as applicable.
As assigned, represent Quality as the Single Point of Contact (Q-SPOC) to the Technical Development Team (TDT) for early stage programs (see Technical Job Roles section below).
As assigned, act as a Delegate of the Swiss Responsible Person (see Technical Job Roles section below).
As assigned, provide expertise, knowledge and guidance for Quality Processes, systems, or both, ensuring operational execution and regulatory compliance, as needed.
Technical Job Responsibilities
Oversee all required quality activities during the lifecycle of a GxP supplier (Source & Select, Implement, Manage and Decommission), including but not limited to: process or method validations, Roche audits, Health Authority inspections, complex investigations, product complaints, and regulatory submissions, as assigned.
Develop, negotiate and maintain Quality Agreements and Product Specific Requirements (as appropriate) with GxP suppliers, as well as with Partners, Collaborators and External Sponsors as applicable, and ensure compliance with agreements.
Collaborate with GxP suppliers to address any gaps in audit responsiveness, CAPA implementation, deviation reporting and management, complaint management, investigation closure, and change implementation with regards to quality and timeliness with the supplier; and escalate as appropriate.
As applicable, manage all required quality activities to support Make Assess Release (MAR) of Roche products including approval of master process documentation, batch documentation review, resolution of investigations, assessment of changes, and monitor and report GxP Supplier quality performance.
As applicable, release, reject or quarantine Roche products (drug substance or API, bulk drug product, and semi-finished and finished products) and medical devices produced within the area of responsibility per applicable Roche requirements, cGMP and the schedule. Support RP and QP Declaration and Certification requirements as applicable.
As applicable, collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods (SAM) in a validated state and compliant with the regulatory dossier, including stability testing programs. Also includes quality oversight for direct material changes, certifications, supplier specifications and internal release specifications, and other documentation.
As applicable, develop and maintain quality risk management plans; utilize risk management tools to identify and mitigate supplier quality and compliance risks, ensuring suppliers are in a state of compliance.
As applicable, manage or lead quality deliverables supporting technical transfers for manufacturing, testing, packaging and product launches at external sites
As applicable, engage in supplier improvement initiatives to solve complex manufacturing or quality problems.
Qualifications and Skills
Ideally, a B.A. or B.S. degree in life sciences or equivalent.
Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience. Experience with GxP suppliers such as CMO, CLO and direct material suppliers is a plus.
Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals.
Ability to interpret quality standards as they relate to GxP suppliers.
Operational Excellence expertise is a plus.
Highly competent in MS office or Google Suite applications including Excel, PowerPoint, Word, and MS Project, etc.
Ability to communicate clearly and professionally both in writing and verbally.
Fluency in oral and written English is a must. Additional language skills are a plus.
This position may require up to 10% domestic and/or international travel.
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.