Basilea Pharmaceutica Ltd. is a commercial stage biopharmaceutical company, headquartered in the heart of the life sciences hub of Basel, Switzerland.
We are an innovative and multinational team of 225 employees worldwide and committed to discovering, developing and bringing to market medicines that make a clear difference to the lives of patients. Our activities are focused on the therapeutic areas of oncology and anti-infectives, with two commercialized drugs in our portfolio (Cresemba® and Zevtera®).
In order to strengthen our Quality Unit Department we are looking for an experienced 

Product Quality Leader (PQL) (m/f) 

Your tasks

  • Provide End-to-end quality stewardship of assigned Basilea Product from development to discontinuation. PQLs are the Single Point of Contact from Quality on the Product Operational Team
  • Provide expert quality guidance to the core project team, product operations teams and their respective subteams as well as Technical Operations throughout the product and process lifecycle in particular for the supplier selection process and/or supplier qualification and requalification process
  • Responsible for the product network supplier/partner quality oversight/relationship. Establish a strong relationship with the Quality stakeholder and senior management both internally and with partners and Contract Manufacturing Organizations (CMOs)
  • Accountable for the end-to-end product specific quality strategy definition and drive continual improvement through product and process lifecycle management
  •  In charge of the quality part of product submissions, launch, product supply and lifecycle management activities
  • Implement  a robust Product Quality oversight program across the network including for example product-specific Risks Assessments and completion of their associated risk reduction activities, Single Point of Contact (SPOC) on Product Operational Team, SPOC for Quality on Technology Transfer Teams and site Inspection Readiness activities, redaction and / or approval of Annual Product Quality Review (APQR)
  • Key Contact and management of product-specific quality and compliance issues, provide key quality decisions on these issues to Senior Management
  • Facilitate sites readiness for product pre-approval inspections across the product network

Your profile

  • Higher degree in sciences (e.g. pharmacy, chemistry or biochemistry)
  • Minimum 5 years of relevant experience in Quality or Operations for investigational and marketed medicinal products
  • Excellent knowledge of cGMP procedures, GDP considered beneficial 
  • Excellent communication skills at different levels
  • Strong support function for development, commercial team and supply chain team
  • Close collaboration and interaction with EU Qualified Person and with third party contacts at CMOs
  • Sound managing experience with CMOs, Quality Assurance activities and performing audits
  • Ability to work both independently and collaboratively in a team environment with a high level of integrity. Hands-on approach on managing challenges and positive attitude in resolving issues and finding solutions

Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on interesting, cross-functional projects in an engaging working environment. We strongly believe that every employee can make an impact and is vital to our success.

If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application via our careers portal.
Additional information can be found on our website