Quality Assurance GCP/GPvP Manager

Full Time
Posted 2 years ago

A leading biopharmaceutical company employing over 2000 professionals covering all key markets around the world. Headquartered near Basel, Switzerland, our functional center is a symbol of our innovative spirit and culture.

Searching for breakthrough medicines for high unmet medical needs inspires and motivates working towards achieving our overriding mission: to treat more patients with groundbreaking therapies.

Besides highly competitive compensation and tangible benefits, would you like to have a noticeable impact and enjoy a culture of innovation, trust and teamwork? Do you want to grow in a different kind of company with an enthusiastic, stimulating environment fostered by open communication and a results-driven approach?

Job Responsibilities

  • Quality Assurance Affiliate Program
  • Act as global quality contact to all Affiliates worldwide and maintain close relationships with local Quality counterparts, providing support, training and consultancy on local Quality Systems and GxP topics
  • Actively support the Affiliates in establishing and maintaining a local quality system
  • Keep abreast of organizational developments in the Affiliates as well as local regulations/requirements in the respective countries
  • Contribute to the organization and the content of the yearly global quality event
  • Audits and assessments
  • Conduct audits at affiliates with a primary focus on pharmacovigilance, GCP as appropriate
  • Conduct audits and assessments of CROs (to be) contracted for post-marketing studies (interventional and non-interventional)
  • Procedural documentation
  • Develop and maintain procedural documents for Post-Marketing Quality Assurance
  • Participate to the development of corporate SOPs as appropriate

Candidate Requirements

  • University degree in a business related or scientific field
  • At least 4 years of operational experience in GCP study management
  • Experience of QA/Auditing in the pharmaceuticals industry
  • Sound knowledge of GCP and pharmacovigilance regulations/guidance documents and understanding of their practical implications
  • Strong team player with service oriented mindset
  • Excellent interpersonal skills, i.e. ability to build constructive relationships, positive and constructive attitude, desire and ability to work in interdisciplinary and multicultural teams
  • Excellent communication skills including presentation and listening/consulting skills
  • Proactive approach and capable to work independently
  • Strong analytical and decision-making skills
  • Ability to prioritize tasks
  • Available to travel 20% of the time
  • Fluency in written and spoken English

What the Company Offers

  • A competitive salary and generous social benefits
  • The possibility for development and advancement within our dynamic organization
  • The innovative and stimulating atmosphere of a multicultural environment

The facilities are located in Switzerland, France and Germany

Send your CV to JChandler@acr-uk.com using the job title as the email subject line