QA Manager CMO Management - R&D to Commercial
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, the company covers the entire value chain. Focus is put on late-stage research and development, patient access, and commercialization, realized through co-development agreements with international big pharma.
Within the Global QA Team, you will be the Single Point of Contact for all QA matters. From the release of API, Drug Product, and Finished Goods, you will 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 as SME for the organization and product teams in GMP/GDP related topics
* Pursue compliance and quality-related topics both internally and externally with CMOs and suppliers
* QA representative in project teams for tech transfers or launches of products to new markets
* Handle and assess deviations, change controls, and support in product complaint investigations
* Release of products as QP Delegate
* Participate and support both external and internal audits including authority inspections
* Develop quality assurance standards and company processes
You will establish strong relationships with the Quality stakeholders and Senior Management internally, with partner companies, and CMOs.
Your profile:
* B.Sc, M.Sc, or 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
* Ability to liaise between R&D, Commercial, and Supply Chain
You have an open mindset, curiosity, and the ability to share your knowledge with diverse stakeholders. You possess the proven ability to highlight the most relevant impacts to secure compliance of the products you are assigned to.
You are a quality influencer throughout all steps in the multi-site supply network and are talented in building trustful and effective relationships.
Seniority level
Associate
Employment type
Full-time
Job function
Quality Assurance
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