Gxp Audit Team Lead

vor 7 Monaten

Basel, Schweiz Sobi Vollzeit

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

**Role & Function**

The GxP Audit Team Lead supports the organization through the strategic planning and execution of audits to assess compliance with GxP (GCLP, GCP, GDP, GMP, GVP, including CSV requirements). Ensured by: - Consistent implementation of processes and procedures in the delivery of the audit program and execution of the audit strategy. - Principal lead to developing and execution of the Inspection Management Strategy for the Sobi organization.

**Key Responsibilities**
- Responsible for the GxP Annual Audit Plan working in conjunction with the GxP Quality SMEs.
- Responsible for the execution of Audits according to the Audit Program
- Ensure audits are resourced, conducted, and reported in accordance with applicable SOPs, department manuals, and the annual audit program
- Responsible for reviewing audit deliverables such as draft audit plans and draft audit reports
- Responsible for ensuring timely closure of audits and appropriate CAPA plan review and approval
- Escalate compliance issues/risks to Senior Management as appropriate
- Responsible for the development and execution of Sobi Inspection Management Strategy working in conjunction with other Quality functional heads
- Support the preparation for and hosting of regulatory authority inspections
- Responsible to provide regular key learning and strategic insight from internal and external audits and audit related processes
- Maintain knowledge of company policies, SOPs, and supporting documents related to drug development/manufacturing/distribution as well as FDA and EU regulations and ICH guidance documents (as applicable) along with any other national or international regulations
- Perform Audits as Lead Auditor as needed
- Lead the QA Auditor Team

**Qualifications**
- University degree in Life Sciences or related discipline.
- At least 15 years’ experience from the pharmaceutical industry with GXP responsibilities.
- Experience of working with GXP audits/inspections
- Excellent knowhow of the EU/US/RoW regulations within GMP/GDP/GLP/GCP /GVP
- Excellent verbal and written communication skillsDesired: Experience working as Inspector, or managing auditor teams

**Personal attributes**

In order to be successful in this position you should be able to live up to our core values:
Care, Ambition, Ownership, Urgency, and Partnership, in addition to:

- Delivery focused - Collaborative
- Structured and detail oriented
- Strong individual initiative with multi-tasking abilities
- Demonstrate a mature organizational/people skills 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.

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 patie

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