Sr QA Supplier Manager

vor 1 Monat

Basel, Schweiz Sobi Vollzeit
Job Description

The QA Supplier Manager is responsible for a wide range of activities related to the Quality oversight of external suppliers in charge of the manufacturing activities for a product. Acting as a single point of contact with the external supplier, the QA Supplier Manager has a key role to ensure compliance of the external supplier with current GMP & GDP regulations, the Quality Technical Agreement and with Sobi procedures and policies to enhance the product supply of medicines to consumers and to support the fast growth of Sobi. This role is also responsible for managing the quality interface and cross-functional relationships with Sobi stakeholders

Key Responsibilities:

  • Serve as the primary contact for all quality-related activities with external suppliers.
  • Ensure compliance with GMP regulations and Sobi's Quality System.
  • Oversee supplier qualifications, and quality technical agreements.
  • Release commercial products on QP Delegate
  • Implement and maintain quality risk assessments and KPIs.
  • Manage quality issues, audits, and change requests.
  • Lead quality initiatives and act as a quality representative in projects.

Qualifications

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

In order to be successful in this position you should have a great understanding of the GMP requirements. You are comfortable in a global and complex environment; able to coordinate people to reach our goals; have interpersonal and leadership skills with ability to influence external Suppliers in a cross-functional environment to foster decisions and to propose solutions. Furthermore, you have great collaborative skills to develop strong relationship within Sobi but also with the External Suppliers

 

  • High level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science
  • More than 7 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP)
  • Proven track record with FDA; EMEA or other Health Authorities
  • Strong understanding of risk assessment and risk management fundamentals / tools
  • Fluently spoken and written English


Additional Information

Why Join Us?

We are a global company with over 1,800 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

Sobi Culture

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

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