For our client a development stage oncology company, we are looking for a Senior Quality Manager.
The company focuses on the identification, license acquisition and development of products from preclinical to phase 2 in oncology. The Senior Quality Manager will be responsible for the Quality Management System (QMS) and lead QA activities. They will provide Quality direction, training, and support to the company team and collaborate with CROs, CMOs and contract laboratories to ensure quality and GxP compliance is met.
Main duties and responsibilities
Build QRM plans and identify risk mitigation plans
Execute the risk management plan to support company activities
Ensure business activities are conducted in compliance with the regulations and standards applicable to Onward business
Develop, implement, and maintain the organization’s QMS
Propose and/or review policies, SOPs, and other quality documentation
Promote quality assurance principles across the company and ensure that all aspects of the QMS are understood, implemented, and maintained by company employees·
Track key performance metrics and trending of quality systems
Support implementation of quality systems and processes, including tracking of all investigations, deviations, and Corrective and Preventative Actions (CAPAs)
Assess the need (or not) to be certified, and recommend the corresponding action plan when necessary
Review all investigations and follow up with CAPAs
Participate in vendor management evaluation
Review and approve quality agreements with CMOs, CROs and contract laboratories.
Provide quality oversight of preclinical and clinical development programs including subcontracted activities (external CRO, CMO, contracted laboratories)
Contribute to the preparation of regulatory dossiers
Manage internal and external quality related audits for the Company
Qualifications and experience
Bachelor’s degree in science, pharmacy, or engineering. Advanced studies in quality management, or related field would be a plus
A minimum of 5 years of experience in quality assurance, preferably in the bio/pharmaceutical industry
Involved in continuous improvement activities
Fluent in French and English. German would be a plus
Analytical, problem-solving, and critical-thinking skills
Organized, rigorous and precise
Team-spirited, sense of service and excellent communication skills allowing him/her to maintain excellent relations with his/her colleagues
“Startup mindset”: taste for innovation, flexible and adaptable
Expertise in Microsoft office computer software
Please contact firstname.lastname@example.org for a full job description.