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.
A propos de nous
Le Groupe Vifor Pharma est une entreprise pharmaceutique internationale. Il occupe une position de leader dans toutes ses activités clés et se compose des entreprises suivantes: Vifor Pharma et Vifor Fresenius Medical Care Renal Pharma (sa société commune avec Fresenius Medical Care). Le Groupe Vifor Pharma est coté à la Bourse suisse (SIX Swiss Exchange, VIFN, ISIN: CH0364749348.