Job Description
Clinical Quality Assurance Lead, GCP
Our client, a young drug development biopharmaceutical company with an early stage product development pipeline, have approval for a new role Quality Assurance Lead who will report to the Chief Medical Officer (CMO).
The successful candidate will represent QA within project teams providing input, strategies and options, ensuring a Quality culture is present throughout the organisation. This hire will provide project teams and customers, quality guidance that is commensurate with the stage of development and be proactive for commercialisation.
Additionally, this hire will have responsibility for the oversight and maintenance of the Quality Management System (QMS) and Quality Assurance (QA) management within the company.
Person fit: the ideal candidate will be a GCP Quality Leader who is self-driven and capable of working on their own initiative in a fast-paced dynamic environment. Proven track record in Quality Assurance; leading GCP audits and overseeing compliance with all GCP, GLP and GMP requirements. Travel approx. 15% depending on operational activities.
This is a permanent role based in Dublin, with flexibility for the right candidate.
Requirements for Clinical Quality Assurance Lead, GCP:
Bachelor’s or Masters Degree in a Scientific discipline or related field.
8+ years Quality Assurance experience in industry, of which 3+ years’ experience in pharma/biotech Clinical Quality Assurance (GCP).
Extensive knowledge of QA systems in GxP environments.
Proven auditing experience of GxP suppliers/vendors.
Proven knowledge of regulatory/compliance requirements, especially those applicable to GCP.
GMP experience is preferred.
Extensive experience developing and implementing Quality Agreements.
Knowledge of relevant regulatory requirements.
Excellent interpersonal, communication, and problem-solving skills.
Strong computer skills.
Flexible in reacting to changing priorities in a dynamic business environment.
Demonstrated coaching/mentoring skills.
Attractive salary and benefits offered, dependent on experience.
For further details, please contact Larry on +353 (0) 1-2302400 / larry@rftgroup.ie
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
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