Kelly Scientific is looking for its Life Science partner a Head of QA Operations
The Head of QA Operations is a key partner of the organisation and works in close collaboration with the corporate departments (e.g: QMS, Supply Chain, Development, Regulatory Affairs, Sales) as well as with external partners including affiliates, customers and third parties contractors such as Contract manufacturers, API Suppliers, distribution centres and laboratories.
The Head of QA Operations manages, directs and supports the Quality Assurance Operational staff activities to ensure compliance with all established systems and processes as per current régulations.
The Head of QA Operations monitors compliance and business needs with appropriate departments to ensure operational objectives achievement.
People Management :
- Lead, manage, develop, train and evaluate QA Operations staffing
- Provide input to QA Operations staffing for the good performance of their responsibilities
Operations Management :
- Determine objectives, strategies, systems and procedures
- Play the Interface role and provide input to QMS for the establishment, maintenance and improvement of quality processes and procedures such as change controls, deviations, complaints, investigations, CAPA plan and risk quality management
- Ensure quality oversight of the day-to-day operations at suppliers and contract manufacturers as per corporate policies and applicable US and European regulations such as but not limited to Pharmaceutical, Food Supplements and Medical Devices requirements
- Support alert and batch recall process
- Maintain KPI systems running
- Support quality agreement negotiation with relevant partners when required
- Provide support to customers for QA operations topics
- Pharmacist or equivalent degree in a Life Science, with at least ten (10) years of relevant experience
- Knowledge and understanding of regulations including but not limited to cGMP as defined by the US Food and Drug Administration and European Medicines Agency
- Working knowledge of current global initiatives including but not limited to Quality by Design, Process Validation and Data Integrity
- Experience with Contract Manufacturers Organization (CMO) and cross functional team
- Experience of successfully managing a team with leadership
- Strong team orientation including the ability to coach and mentor
- Strong written and verbal communication skills
- Accountable for making independent decisions regarding daily QA Operations with minimal supervision
- Fluent in French and English
Thanks for applying online
Your contact at Kelly:
Mrs Sophie Darthenay
Consultant Professional Staffing Life Science
Kelly Scientific Geneva
Kelly Services® is a global leader in providing staff solutions and active in more than 40 countries.
Together with its subsidiaries, Kelly offers a wide variety of outsourcing and consulting services as well as staff services,
from permanent and management positions to temporary positions.
For over 70 years, we have worked with passion and commitment to connect talents with companies.
With more than 200 employees in over 40 branches and specialist departments,
Kelly Services (Switzerland) AG has been active in Switzerland since 1979.