We are currently seeking a Quality Assurance Manager (m/f) to maintain and enhance our Quality Management System (QMS) and to ensure that our products compliant with the regulatory requirements. The goal is to assure the high quality of our developments and operations aiming to the long-term success of our business.
- Perform overall SOP (Standard Operating Procedures) management and development,
- Verify compliance with GCP guidelines and other relevant local and international regulations,
- Identify and investigate quality issues,
- Identify, develop and implement quality systems and process improvement opportunities,
- Provide guidance to Clincase staff regarding compliance issues and SOP interpretation,
- Develop regulatory trainings and training materials,
- Implement proper document management and change control processes,
- Implement CAPA management tools and strategies
- Schedule, plan, conduct and report on internal and external audits,
- Manage preparation for audits, represent Clincase during external audits and conduct review and strategy relating to audit results
- Stay up-to-date, and keep management up-to-date on developments in regulatory landscape
- Share information in an open, balanced and objective manner
- Implement benchmarking practices and perform other tasks as needed
- Work in close collaboration with the V&V Manager to implement a comprehensive compliance regime.
- A Bachelor’s degree in life sciences, biotechnology, medicine or other related degree programs
- 3+ years of experience in a Quality Assurance role in the life sciences industry with a demonstrated expertise in regulations affecting our industry (i.e. FDA CFR part 11 and EU Annex 11 and related guidance publications) and GCP.
- Able to work with limited supervision, a self-starter
- Has strong communication and organizational skills
- Independent-minded, but comfortable working in a team environment
- Enthusiastic about well-defined and well-implemented processes
- Fluent in English (written and spoken)
- Proficient in German (C1 or C2 level)