Product Quality Leader

The role involves providing end-to-end quality stewardship from development to discontinuation, ensuring compliance and quality throughout the product lifecycle.

• Provide End-to-end product quality stewardship from development to discontinuation. Act as the Single Point of Contact from Quality on the Product Supply Chain Team
• Provide expert quality guidance to the technical operations teams throughout the product and process lifecycle in particular for supplier selection process and/or supplier qualification and requalification process
• Accountable for the end-to-end product specific quality strategy inclusive product release and drive continual improvement through product and process lifecycle management
• Accountable for the implementation of a robust Product Quality oversight program across the network including: product-specific Risks Assessments and completion of their associated risk reduction activities
• Redaction or approval of Annual Product Quality Review (APQR), Escalation of product-specific quality and compliance issues for review at relevant Global Quality Review Board and Senior Management
• Facilitate sites readiness for product inspections across the network
• Lead, actively engage in and support global quality programs
• Approval of GMP related documents
• Accept/reject suppliers according to internal QM guidelines with focus on QA GMP issues.
• Accept/reject APIs, drug products, IMPs and MMPs
• Represent QA for GMP within the project teams, in meetings with authorities, customers, partners and CMOs

• Ensure overall end to end GMP/GDP compliance for products in the commercial phase incl. quality life cycle management.
• Define the overall product Quality strategy
• Write and approve Technical agreements
• Approve quality relevant documents for assigned products and external suppliers
  
  Ensure timely release of the product
• Ensure compliance with TA in the area of responsibilities
• Assess deviations, investigations, product quality complaints, OOS and CAPAs and support change control of assigned products
• Support EU Responsible Person in all relevant matters
• Support hosting and preparation of Health Authority or Partner inspections at supplier site or at Basilea
• Support the overall Basilea continuous Q improvement project
• Establish, update and maintain GMP/GDP related QMS documents
• Support budgeting and cost control of assigned tasks