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Hobson Prior are looking for a QA Director to join a top science-based biopharmaceutical organisation to join them on a permanent basis in Uxbridge or Dublin. As the QA Director you will support the Senior Director, GCP Quality with GCP / GvP quality oversight of Pharmacovigilance vendors used in the conduct of clinical trials.
- Represent as a point of contact between the organisations GCP Quality; Pharmacovigilance (Quality) Representatives and the Quality representatives of Pharmacovigilance and CRO vendors contracted to conduct clinical trials for the organisations.
- Responsible to ensure effective escalation and assessment of significant issues, via the Suspected Serious Non-Compliance process, for any issues that potentially represent serious GCP / GvP non-compliance or serious breaches.
- You will assist with implementation of Quality Agreements for relevant 'top tier' vendors.
- Deliver input to the definition for Key Quality Metrics for vendors and co-operate with the Metrics and Analytics group to review those metrics on a regular basis.
- Provide consultation, guidance, training and support to the team in respect to compliance with applicable international pharmacovigilance regulations, practices and guidelines.
- Provide review, input and approval of any CAPAs associated with GCP / GvP non-compliance or audits of those vendors, including serving as the CAPA (Oversight) lead for any significant / systemic issues attributed to the vendors processes and/or systems.
- Work closely with the CPMO Vendor Management group, communicating any quality issues and support implementation of effective quality oversight and input into vendor risk assessments, as appropriate.
- Lead and/or support process improvement initiatives and work groups relevant to the organisations effective oversight of its vendors.
- Act as a back-up to the Senior Director, GCP Quality (Vendor Quality), attending the Outsourcing Strategy team meetings to provide GCP input and approvals in relation to the vendor qualification process.
- Offers advice and briefings on regulations to support compliance strategy and policy.
- Establish and maintains close working relationships with staff to ensure compliance risks, issues, and breaches are effectively managed and resolved.
- Excellent leadership skills
- Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations
- Critical thinking & problem solving
- Excellent interpersonal skills
- Organizational & political savvy
- Bachelors or Master's degree with at least 10 years of relevant industry experience.
- Thorough knowledge and application of international requirements of Good Clinical Practice and ICH E6 R2 Guidelines.
- Experience with Regulatory Inspections (e.g. FDA, EMA, MHRA, etc.)
- Strong global knowledge and understanding of regulations applicable to the conduct of clinical trials.
- Strong working knowledge of clinical development and operations.
- Experience in providing training on key quality and regulatory compliance information.
- Knowledge relevant national/international pharmacovigilance regulations, including but not limited to EU Good Pharmacovigilance Practices, EudraLex Volume 10 (CT-3) and applicable FDA Codes of Federal Regulation.
- Extensive CRO and/or other vendor experience preferred.
- Strong PC literacy required; MSOffice skills (Outlook, Word, Excel, PowerPoint).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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