Program Management Data Integrity - St. Gallen

Employer
Vifor Pharma
Location
St Gallen, Switzerland
Salary
Competitive
Closing date
16 Oct 2020

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Discipline
Project Management
Hours
Full Time
Contract Type
Permanent
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About You

We are currently looking for a Program Manager Data Integrity to join our Corporate Quality team. This role reports directly to the Head of Corporate Quality IT and is planned to be based in St. Gallen.

Your responsibilities will include:

  • Lead the Data Integrity Program across multiple sites and functions
  • Lead and supports associated programs or projects (e.g. the paperless laboratory initiative, (Secure Production and Laboratory Network (SPLN) project)
  • Creation, review or approval of all Data Integrity related corporate Policies and SOP's
  • Act as a quality lead in all Data Integrity related committees or boards (e.g. the DI Steering Committee)
  • Help ensuring a compliant validation status and inspection readiness of data integrity critical systems (e.g. LIMS, Chromeleon, Empower, SPLN)
  • Perform periodic reviews of data integrity critical systems
  • Support in assuring Data Integrity and Data Governance standards of all Vifor Pharma IT Systems in GxP areas
  • Conduct and support IT vendor, contractor and supplier audits initially as co-auditor and after a training phase if requested as lead auditor
  • Present and defend the Corporate QM systems, corresponding validations and requirements during inspections and customer audits


The successful candidate is willing to work effectively with a wide variety of personnel across diverse teams and functions internally as well as external partners. In addition, you will bring the following profile:

  • Degree in Pharmacy, Chemistry, Chemical Engineering Science or similar
  • 4 to 8 years work experience in a QA, QC, QM or Project Management department in the Pharmaceutical, Chemical, Medical Device or related Industry. As an alternative a high skilled studies graduate may be selected
  • Work experience as Program and Project Manager of global Programs in Life Science Industries
  • Work experience in regards to Data Integrity and related initiatives like Paperless Laboratory and Secure Production and Laboratory Networks
  • Sound knowledge in document management
  • Auditing experience, experience with Health Authorities Inspections
  • Demonstrated ability to successfully collaborate across different sites, functions, management levels
  • Fluency in English both verbally and in written, German and French language skills of advantage
  • Good knowledge of Microsoft Office Applications (e.g. Word, Excel, PowerPoint, Visio) and MS Project


You describe yourself as a fast and keen learner, with strong teamwork skills and a positive attitude. You demonstrate accuracy and attention to details with a focus on quality compliance requirements. Finally, you are able to cope with stress and demonstrate discretion in the handling of confidential information.

About Us
The Vifor Pharma Group is a global specialty pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma.

Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

For more information, please visit www.viforpharma.com/career

We are looking for new people to join an international team of more than 2,700 talented people, operating in over 100 countries to support our Vision of becoming global leader in our three therapeutic areas:

IRON DEFICIENCY

 

NEPHROLOGY

 

CARDIO-RENAL

 

WHY VIFOR PHARMA

We are a global leading expert in iron deficiency and iron deficiency anaemia.

We are proud of a broad portfolio to help nephrology patients suffering from kidney disease.

Our expertise in both these areas are helping cardio-renal patients.

We innovate internally, but we also partner with the best companies externally. We are also a unique pharmaceutical company, as we have direct access to Fresenius Medical Care clinics via our joint company. Fresenius Medical Care has access to more than 329,000 patients in its global network of over 3,900 dialysis clinics.

Contact Us
  • Flughofstrasse 61
  • 8152 Glattbrugg
  • Switzerland
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