HEAD OF R&D QUALITY ASSURANCE

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 Scientific Operations Division in Lugano we are looking for a:

HEAD OF R&D QUALITY ASSURANCE

Responsibilities include:

  • Assure the implementation and maintenance of an effective and efficient Quality Management System in accordance with the GXP rules and regulations (GCP, GMP, GLP and GVP) and Helsinn Group Quality Manual
  • Formulate GXP compliance strategy and provide advice for all programs in collaboration with key stakeholders and Group QA
  • Assess GXP compliance risk areas and develop and implement risk mitigation measures
  • Manage QA reviews of essential R&D documents as well as regulatory authority inspections
  • Ensure appropriate evaluation of service providers as part of the vendor selection process
  • Provide compliance guidance to audited parties and serve as an expert in the interpretation of GCP, GMP, GLP and GVP regulatory requirements and expectations
  • Plan and lead GXP compliance audits, develop and prioritize audit strategies
  • Report audit findings as well as major and critical un-compliance to the Division management and Group QA
  • Coordinate and support the activities in case of Group QA, Partner audits and Regulatory Authorities inspections
  • Cooperate with Group QA in defining and implementing Group Policies, Group Quality Manuals and metrics

The successful candidate has the following qualifications:

  • At least 5 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
  • Technical competences in clinical development and Quality Assurance associated with brilliant analytical and organizational skills; precision and synthesis are essential
  • In-depth knowledge of and ability to interpret and apply GCL, GMP, GLP, GVP EU, FDA and ICH regulations, guidelines, and best practices
  • 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, availability to frequent business trips, strong analytical skills, problem solving ability, accuracy, ability to think critically, listening ability and assertive behavior are required
  • 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 and a pleasant working environment in a highly motivated team.

Please send relevant application with CV to:

http:// helsinn.jobopportunity.ch