Gcp QA Manager

vor 2 Wochen

Basel, Schweiz Sobi Vollzeit

**_Role & Function_**

To provide QA support and quality oversight to the clinical organisation within Research, Development and Medical Affairs (RDMA) in compliance with applicable GxP requirements. This position will be based in Sweden or in Switzerland.

**_ Key Responsibilities_**
- Within Global GxP Compliance & Quality Systems department, provide active support in the development and continuous improvement of the Quality Management System and related documentation system, as appropriate.
- Contribute to the monitoring and reporting of KPIs and metrics related to quality processes, and to the preparation and reporting of Quality Reviews.
- Act as QA representative in the department Global GxP Compliance & Quality Systems, for operational teams and support functions (e.g. represent QA in team meetings or project-specific meetings) within the R&D and Medical Affairs organization
- To review and give guidance to the development of clinical SOPs owned by RDMA.
- To review and give guidance to the development of SOPs in relation to Investigator Sponsored Studies (ISS) and Market Access Programs (MAP).
- To collaborate with QP IMP and review and give guidance in relation to IMP management and Quality agreements to ensure GCP compliance.
- Act as Quality approver of clinical and ISS/MAP SOPs owned by RDMA.
- Actively contribute to problem solving, give support to operational teams and support functions as regard to quality related issues

**_ Qualifications_**
- Degree in life science (pharmacy, biological sciences, chemistry, or related field).
- Good knowledge of applicable ICH GCP guidelines, industry best practices and regulatory requirements.
- Documented education/experience in QA systems and preferably auditing

**_ Personal attributes_**
- Delivery focus
- Collaborative
- Structured and detail oriented
- Strong individual initiative, organizational/people skills and multi-tasking abilities

In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership

**_ Location_**

The position will be based in Switzerland.

**_ Reporting to_**

GCP/GVP QA Head

**_ Recruitment contact & how to apply_**

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

**Why Join Us?**

We are a global company with around 1,500 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.

**An Equal Opportunity Employer**

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