QA Manager CMO Management - R&D to Commercial

End to End Quality Stewardship - Basel

--- | Our customer is an innovative international biopharmaceutical company with offices in Basel. Intense R&D activities gave rise to an exciting pipeline of new promising drugs, many of which successfully reached commercialization stage. With a strong portfolio of on-market products, and an extensive portfolio of pre-market assets company covers the entire value chain. Focus is put on late-stage research and development, patient access and commercialisation. This is realised as well with co-development agreements with international big pharma. Within the Global QA Team you will be Single Point of Contact for all QA matters. From release of API, Drug Product and Finished Goods you provide end-to-end quality stewardship of your assigned product from development to delivery to warehouse. You will deal with Biologicals, Steriles and Non-steriles in multiple dosage forms. Your responsibilities: * Act SME for the organization and product teams in GMP/GDP related topics

• Pursue compliance and quality related topic both internally and externally with CMOs and suppliers
• QA representative in project teams for tech transfers or launches of product to new markets
• Handle and assess deviations, change controls and support in product complaint investigations
• Release of products on QP Delegate
• Participate and support both external and internal audits including also authority inspections
• Develop quality assurance standards and company processes

You establish strong relationships with the Quality stakeholder and Senior Management both internally, with partner companies and CMOs. Your profile: * B.Sc, M.Sc, PhD in Life Sciences

• > 5 years of experience in Pharma QA Operations
• QA Experience in a manufacturing environment and batch release, QP-delegated tasks
• Sound managing experience with CMOs, Quality Assurance activities and performing audits
• Liase between R&D, Commercial and Supply Chain

You have an open mindset, curiosity and the ability to share your knowledge with diverse stakeholders. You have the proven ability to point out most relevant impacts to secure compliance of the products your are assigned to. You are a quality influencer throughout all steps in the multi-site supply network and are talented to build trustful and effective relationships. |