QA Gvp Manager

vor 24 Stunden

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.**

**QA GVP manager***:
**Role & Function**
As a GVP manager you are responsible for ensuring quality oversight and support of the PV activities within Sobi. To build and develop the audit strategy, program and plans within the PV area. Perform and coordinate PV audits internally in Sobi, Partners and externally at external service providers. Support and collaborate with Drug Safety,Medical Affairs, Regulatory Affairs and Affiliates as necessary.

The employee will in this role work with relevant stakeholders across the Sobi organization: R&D (Clin/Drug Safety, RA), Medical Affairs, Commercial and GQ&C.

**Key Responsibilities**:
SOP Author for SOPs related to GVP audits including supporting documentsPerform SOP approval within R&D and Medical Affairs area (excluding CMC part)Prepare the GVP audit strategy according to SOPs.Prepare audit programs according to SOPs.Ensure audits are performed with internal auditors and external auditors as needed.

Prepare budget and budget follow-up for costs related to audits performed by contractors.

Prepare regular status report on performed audits, audit trending and agreed upon metrics to ensure Quality oversight

Quarterly updates to audit related information to the PSMF

Ensure documented qualification of GVP service providers

Participate as QA representative during PV inspections and partner audits

**Qualifications**:
University degree in Life Sciences or related discipline.At least 5 years experience from the pharmaceutical industry with GVP responsibilities.GVP audit experienceExcellent knowhow of the EU/US/RoW regulations within GVPExcellent verbal and written communication skills

**Personal attributes**
In this role you need to have a strong delivery focus and ability to work and communicate well with internal and external stakeholders. Working in this role it is preferable to have a flexible attitude but at the same time ability to work structured and detail oriented in a dynamic setting.
Working for Sobi we believe you have and will encourage your strong strategic and initiative thinking as well as you ability to organization and multi-tasking. At Sobi we believe that by taking ownership, acting with urgency because we care about our patient we can and will reach our ambition.

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**
Head of QA GVP/GCP Peter Verdijk.

**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.

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