Quality Assurance Manager, Drug Development
|Contact Name:||Larry O’Leary|
Our client, a young science driven pharmaceutical company with early stage product development pipeline, now seek a Quality Assurance Manager to take ownership for in the Quality oversight and execution of GXP activities.
The successful candidate will lead the design and oversight of quality systems to enable compliant environments pertaining to pharmaceutical development i.e. ensuring GXP regulatory requirements are met during execution of corporate objectives and timelines.
This individual will oversee Quality systems for GMP, GCP, GLP environments. As applicable, this hire will provide project teams and customers, quality guidance that is commensurate with the stage of development and be proactive for commercialisation.
Person fit: Ideal candidate will be a Quality Professional who is self-driven and capable of working on their own initiative in a fast paced dynamic environment.
Responsibilities for Quality Assurance Manager, Drug Development:
Developing strategic vision for the support and oversight of products and Clinical Trial Activities in EMEA, US, ROW.
Conducting, contracting, and or participating in audits of GXP Contract Service Providers.
Hosting Health Authority inspections as applicable.
Lead regional CMO/CRO communication on Quality issues, qualification and oversight.
Lead Quality and Compliance projects to support the European business.
Requirements for Quality Assurance Manager, Drug Development:
Bachelor’s or Masters degree in a scientific discipline or related field.
8+ years’ experience in pharmaceutical Quality Assurance, including experience with the quality oversight of clinical development / drug development processes.
Extensive knowledge of US and European Drug Product GMP requirements and associated guidelines.
Proven relevant experience in QA auditing with continual improvement experience preferred.
Experience in implementation and administration of quality systems for drug Development, manufacturing and quality control operations.
Experience working with both in house and external (contract) GMP facilities.
Extensive experience developing and implementing Quality Agreements.
Able to professionally communicate verbally, in writing and represent the function effectively.
Please contact Larry on +353 1 – 2302400 / email@example.com
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on Twitter, Facebook and LinkedIn