Job Description
Our client, a young science driven biopharmaceutical company with early stage product development pipeline, now seek a Clinical QA Lead who will be responsible for the oversight and maintenance of the Quality Management System (QMS) and Quality Assurance (QA) management within the company
The successful candidate will represent QA within project teams providing input, strategies and options. This individual will be a key member of the company’s management team.
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 Clinical Quality Assurance Lead:
Provide QA leadership and direction.
Responsible for leading activities that result in being a company that is ‘audit ready’.
Develop and enhance the existing QMS and associated quality procedures and policies in compliance with global regulatory requirements in partnership with other functional groups.
Provide ongoing oversight and maintenance of the QMS, identifying opportunities for continuous QMS improvement, ensuring the QMS remains effective.
Development of GxP-compliant procedures to support conduct of pre-clinical, clinical and manufacturing activities.
Provide guidance and direction on quality issues for selected CRO/CMO QA departments.
Lead role in supplier /vendor qualification including conduct or oversight of required audit activities.
Requirements for Clinical Quality Assurance Lead:
Bachelor’s or Masters degree in a scientific discipline or related field.
10+ years’ experience in pharmaceutical Quality Assurance, including experience with the quality oversight of clinical development / drug development processes.
Strong leadership and organisation skills, strong analytical and strategic thinking.
Proven knowledge of regulatory/compliance requirements, especially those applicable to GCP - as well as data protection legislation.
GMP experience is preferred.
Extensive experience developing and implementing Quality Agreements.
Proven relevant experience in QA auditing with continual improvement experience preferred.
Able to professionally communicate verbally, in writing and represent the function effectively.
Please contact Larry on +353 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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