Gxp Audit Team Lead

Vor 2 Tagen

Basel, Schweiz Swedish Orphan Biovitrum AG Vollzeit

**GxP Audit Team Lead**

**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, and/or CSV requirements.GxP Audit Head ensures consistent implementation of processes and procedures in the delivery of the audit program and execution of the audit strategy.The GxP Audit Team Lead supports the organization developing and executing the Inspection Management Strategy for Sobi.

**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 Seniore 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 skills
- Desired: Experience working as Inspector, or managing auditor teams

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

**Location**
The position will be based in Switzerland.

**Benefits**:

- Company pension
- Long-term profit-sharing plan
- Work from home

Schedule:

- Monday to Friday

Supplemental Pay:

- Performance bonus

**Experience**:

- from the pharmaceutical industry with GXP responsibilities: 10 years (preferred)

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