Our customer is an innovative pharmaceutical company located in Basel. Intense R&D activities gave rise to an exciting pipeline of new promising drugs, many of which successfully reached commercialization stage. The Technical Operations department is in charge of development, production, supply, and distribution together with numerous external partners and CMOs. Growing volumes result in an increased complexity of the processes. Our customer is therefore adapting the organisational structure and creating a new role with a high visibility and a strong impact on the company’s future success.

QA Manager for external supplier GMP-GDP compliance

• Provides Quality oversight of external GDP operations.
• Leads Supplier and Service provider qualification activities, including audits and management of Technical Quality Agreements with Suppliers and Service Providers
• Support Batch Record review, release preparation and batch disposition of commercial APIs, bulk drug product, and finished products manufactured by contract manufacturers

Your tasks:

• Provide Quality oversight of external GDP operations
• lead QMS activities, Complaints, Deviations, Change Control, Audits, Self-Inspections and Training
• Support Batch Record review, release preparation and batch disposition of APIs, bulk drug product, and finished products manufactured by contract manufacturers on behalf of Basilea.
• Monitor performance metrics, provide regular updates to management on assigned project progress, and escalate challenges as needed.
• Execute and support external and internal audits (GDP/GMP).
• Support Health Authority inspection and customer audits preparation and management.

Your profile:

• B.Sc, M.Sc. Life Sciences
• > 3 years of experience in Pharma QA Operations
• Experience in Quality Supplier Management
• Excellent knowledge in GMP and GDP regulations

You have an open mindset, curiosity and the ability to share your knowledge with diverse stakeholders, able to point out most relevant impacts to secure compliance of the products your are assigned to.
You act as a quality influencer throughout all steps in the multi-site supply network and are talented to build trustful and effective relationships, knowing your problem solving attitude and clear QA strategy vision will be a key success factor. Your optimistic and enthusiastic attitude will be an asset in the familiar QA setting.