GCP QUALITY MANAGER

Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology.

In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.

For our Quality Assurance department in Lugano we are looking for a:

GCP Quality Manager

Responsibilities include:

  • Assure the compliance of Scientific Operations Division Quality System with the GXP rules and regulations (GCP, GLP, GVP) and Helsinn Group Quality Manual
  • Assure the updating of Scientific Operations Division SOPs
  • Manage QA reviews of essential R&D documents as well as regulatory authority inspections
  • Cooperate in the Quality Management of Clinical Studies
  • Cooperate in the Project Risk Management activities
  • Ensure appropriate evaluation of service providers as part of the vendor selection process
  • Plan and lead GCP,  GLP and GVP compliance audits, develop and prioritize audit plans
  • Perform Sponsor audits at investigational sites and Services Providers that support Helsinn Clinical Studies.
  • Carry out internal audits
  • Cooperate in the investigation of major and critical deviations

The successful candidate has the following qualifications:

  • At least 3 years of experience in clinical development or QA spent in pharmaceutical companies or CROs /Research Institutes are necessary to cover this position
  • Degree in pharmaceutical or biomedical science (medicine, biology, pharmacy, chemical and pharmaceutical technologies) is requested
  • In-depth knowledge of and ability to interpret and apply GCL, GMP, GLP, GVP EU, FDA and ICH regulations, guidelines, and best practices
  • Technical competences in clinical development and Quality Assurance associated with brilliant analytical and organizational skills
  • Experience reviewing and auditing study-related documentation and with regulatory inspections and quality management systems
  • Fluency in written and spoken English is essential
  • IT systems competence (Excel)
  • Availability to frequent business trips
  • Good interpersonal and communication skills relating well at all levels, both internally and externally are fundamental
  • High motivation in identifying and perceiving assigned tasks is required
  • Overall vision activities ability and skills in planning and organizing project activities, within budget, are requested

Helsinn Healthcare SA is offering attractive conditions, a pleasant working environment in a highly motivated team and a long-term perspective.

Please send relevant application with CV to:

http:// helsinn.jobopportunity.ch