End to End Quality Stewardship for Assigned Products
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.
As QA Manager you are the Single Point of Contact from Quality on the Product Operational Team and provide end-to-end quality stewardship of your assigned product from development to delivery to warehouse. You provide expert quality guidance to the product and technical operations teams throughout the product and process lifecycle in particular for the supplier selection process, supplier qualification and requalification process. You will be accountable for the product network partner oversight as QA representative.You establish strong relationships with the Quality stakeholder and Senior Management both internally, with partner companies and CMOs.To keep relevant oversight you implement a robust Product Quality Program across the Supply Network including for example product-specific Risk Assessments and completion of their associated risk reduction activities.You are SME and Single Point of Contact (SPOC) on Product Operational Team as well as you act as contact person for Quality on Technology Transfer Teams and site Inspection Readiness activities. You support the redaction and / or approval of Annual Product Quality Review (APQR).
You are SME for the quality part of product submissions, launch, product supply and lifecycle management activities. You will be invoved in Site Inspection Readiness activities and escalate product-specific quality and compliance issues to provide key quality decisions on these issues to Senior Management.
Your profile:
- B.Sc, M.Sc, PhD in Life Sciences
- 3-6 years of experience in Pharma QA Operations
- Experience with investigational and/or marketed Pharmaceuticals
- Sound expert knowledge of GMP requirements and relevant Regulatory Affairs procedures
- Liase between R&D, Commercial and Supply Chain
- Sound managing experience with CMOs, Quality Assurance activities and performing audits
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..
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