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17.10.2020

Program Management Data Integrity - St. Gallen

  • Switzerland - St Gallen
  • Vollzeitstelle

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Program Management Data Integrity - St. Gallen

Location: Switzerland - St Gallen
Function: Quality Management
Company: Vifor Pharma
Julia Quentmeier
International Talent Acquisition Specialist
+41 58 851 87 54
Apply
Agency policy
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

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.

Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.

The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are

Apply
Agency policy

Program Management Data Integrity - St. Gallen

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.
Vifor Pharma
Quality Management

Arbeitsort:

Switzerland - St Gallen

Julia Quentmeier
International Talent Acquisition Specialist
+41 58 851 87 54