Job description - Quality Assurance Manager
Alternative job titles
Quality Manager
Quality Assurance Executive
Description
The Quality Assurance Manager ensures that all processes contributing to the performance of a clinical trial are conducted in accordance with ICH guidelines and other regulations. He/she is responsible for the quality assurance department and personnel. The focus of the position is to develop, perform and manage all Quality Assurance related activities such as internal auditing and the development of Total Quality Measurement (TQM) systems.
Qualifications
For a candidate for quality assurance officer, a degree in science or a related field is often required; furthermore, candidates for this position often have a pharmacy degree. The candidate should possess knowledge of GCP, GMP, GLP, and ISO regulations and extensive experience in a relevant field.
Competencies
- Excellent questioning and listening skills with ability to analyse responses
- Understands clients' needs
- Leadership skills including recognising the strengths and weaknesses in others as well as oneself
- Focus on quality, precision, and punctual delivery of results
- Willing to perform additional activities outside own area of expertise
Tasks
- Supervise, manage, support the quality assurance personnel
- Involved in all new QA Clinical activities and in all Clinical QA related trouble shooting
- Responsible for the development of the Total Quality Management System
- Manages and maintains data bases for the quality system and prepares/assists in preparation of annual reports and quality trending reports
- Reports the status of the quality levels of staff, systems and production activities and participates in improvement programs
- Participates in the evaluation of quality events, incidents and possible complaints and the follow-up activities in the GMP departments
- Keep up to date with all related quality legislation and compliance issues
- Represent the company during external inspections
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