Our client, a young science driven biopharmaceutical company with an early stage product development pipeline, now seek a Head of Clinical Quality Assurance who will be a key member of the company’s management team. This is a permanent role based in Dublin, with flexibility for the right candidate.
The successful candidate will represent QA within project teams, providing input to company strategies and management decisions.
This Head of Clinical Quality Assurance role will provide:
- QA leadership and direction
- leadership on supplier / vendor qualification, including oversight of required audit activities
- guidance and direction on quality issues for selected CRO / CMO QA departments
- quality guidance that is commensurate with the stage of development and be proactive pre-commercialisation
- lead interactions with regulatory agencies and regulatory authority inspections
The ideal candidate will be a highly experienced and energetic Clinical Quality professional, who is experienced in working effectively in a fast-paced environment. Proven ability to work collaboratively with others and to achieve common goals.
Requirements for Head of Clinical Quality Assurance:
Bachelor’s or Masters degree in a scientific discipline or related field.
10+ years’ experience in pharmaceutical/biotech Clinical Quality Assurance.
Extensive knowledge of QA systems in GxP environments.
Extensive 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.
Experienced in QA auditing with continual improvement experience preferred.
Strong leadership and organisational skills, strong analytical and strategic thinking.
Effective communication and influencing skills.
Please contact Larry on +353 1 – 2302400 / firstname.lastname@example.org
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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