GxP Supplier Quality Manager at F. Hoffmann-La Roche Ltd - Poland

Shanghai, Shanghai, China -

Full Time

Start Date

Immediate

Expiry Date

26 Mar, 26

Salary

0.0

Posted On

26 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GxP Compliance, cGMP Knowledge, Quality Oversight, Supplier Management, Risk Management, Quality Agreements, Analytical Methods, Regulatory Compliance, Communication Skills, Problem Solving, Project Management, Collaboration, Investigation Management, CAPA Implementation, Quality Processes, Operational Excellence

Industry

Biotechnology Research

Description

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 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. 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. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Responsibilities

Provide quality and compliance oversight for external GxP suppliers and outsourced products, ensuring adherence to cGMP and Quality Agreement requirements. Act as the Quality Point of Contact for designated suppliers and contribute to cross-functional management teams.