Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research, and is seeking a newly created senior management level appointment in Quality Assurance
The broad, challenging position is responsible for Quality oversight and execution of GXP activities in Europe. The incumbent will design and oversee quality systems to enable compliant environments in the European countries to assure all GXP regulatory requirements are met during execution of corporate t objectives and timelines. This individual will oversee all European Quality systems for GMP, GCP, GLP environments. As applicable, the incumbent will provide project teams and customers, quality guidance that is commensurate with the stage of development or commercialization.
The incumbent is the primary contact with European Health Authorities (EMA, MHRA, etc.) and has responsibility for leading inspections and preparing Quality related correspondence. The Head of Quality, Europe, is responsible for managing suppliers and vendors in the European nations. In addition, the successful candidate is responsible for establishing and enhancing policies, procedures and systems to support development and commercial activities in compliance to applicable cGXP requirements in European territories. The successful candidate is also responsible for ensuring the business processes to enable these policies and systems are installed and effective through surveillance and Quality Systems management.
The responsibilities of this position include:
? Developing strategic vision for the support and oversight of Commercial products and Clinical Trial Activities in Europe.
? Conducting, contracting, and or participating in audits of GXP Contract Service Providers.
? Hosting Health Authority inspections as applicable.
? Qualified Person responsible for batch disposition, certification and registration
? Maintaining batch records, leading investigations of deviations and improving change controls for released batches.
? Lead regional CMO/CRO communication on Quality issues, qualification and oversight.
? Lead Quality and Compliance projects to support the European business. (Serialization, etc.)
Have a Ph.D (or equivalent) with at least 10 years, MS with least 15 years of extensive pharmaceutical quality experience, including experience with the quality oversight of both development and commercial manufacturing processes, and experience working with both in house and external (contract) GMP facilities.
- A minimum of 3 years of effective performance at the Directory level, with previous management experience
- Thrive in an entrepreneurial environment where s/he will have significant responsibility to lead quality programs with significant impact on the success of the Company.
- Hold current Qualified Person credentials.
- Extensive experience developing and implementing Quality Agreements.
- Able to professionally communicate verbally, in writing and represent the function effectively.
- Travel may be required (avg. 25% or less), including international travel.