GxP Supplier Quality Manager
Roche · Shanghai
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
The Position
At Roche, we thrive to deliver more benefits to our patients as part of our 10-year Pharma vision.
We serve our patients through external partnerships because access to quality products is every patient’s right. We leverage external partners in order 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 do this through cross-functional collaborations ensuring quality process excellence and continuous improvement.
Your opportunity
- 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, andregulatory 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) ofRoche products including approval of master process documentation, batch documentation review,resolution of investigations, assessment of changes, and monitor and report GxP Supplier qualityperformance.
- 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.
Who you are
- 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.