Franchise Operational QA Manager

On behalf of our client in the Life Science industry, Harvey Nash is looking for a Franchise Operational QA Manager for a 6 month project in Switzerland.

The role

- Guide development teams in quality and compliance decisions
- Provides leadership during development of CAPAs
- Coordinates and review CAPAs and audits
- Identify ways to continuously improve quality and compliance with regulations and standards
- Represent Franchise QA in interactions with internal, external contacts and HA
- Ensure inspection readiness by preparing clinical teams for FDA/EU/key HA pre-approval and sponsor-monitor inspections; provide inspection management support and follow-up post inspection
- Provide interpretation of GCP regulations and company standards, guide- lines, policies and procedures to Franchise personnel
- Drive the implementation of the annual Franchise Quality Plan; identify rele- vant areas to be addressed in future Quality Plans
- Closely cooperate with the Development QA Quality Systems Excellence, Auditing and Compliance Excellence groups to ensure consistency of quality and compliance activities and effective communication

Requirements

- 10 years experience in clinical development or pharmaceutical industry and 3 years specifically in QA and compliance
- Knowledge of international GCP
- Experience with regulations including FDA/EMA/ICH/PV
- BSc/MSc in scientific related field or equivalent
- Fluent English required additional languages are an asset

Are you available immediately, have experience working within a Life Science company? Please send your complete CV (Word documents preferred). For further details feel free to call me. Im looking forward to receiving your application.