QA Associate Director
Hobson Prior are looking for a QA Associate Director to join a top global healthcare provider who have built an innovative business model that focuses on manufacturing inexpensive pharmaceutical products. In addition, our client concentrates on preventing, treating and controlling diseases of animal health.
- Represents as the QA single point of contact for clinical project teams and provides Good Clinical Practice, Good Pharmacovigilance Practice and/or quality advice and guidance for Vaccine studies and other Therapeutic Areas and/or counties.
- Proactively recognises, analyses and leverages quality indicators and data to identify potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies.
- Conducts wide range of GCP and/or GPVP audits, including complex audits, (i.e., directed, for-cause), in accordance with QA risk-based processes.
- In partnership with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments, quality oversight initiatives (quality plan, quality agreements) and the identification of audit substrate.
- Acts as a strong technical resource and is called upon to resolve GCP/PV issues and participate in the development/enhancement of QA procedures, guidance documents and audit tools to ensure QA consistency globally.
- Ensures appropriate and timely escalation of quality issues, including potential misconduct or issues of significant deviation with projects/products, to the QAL and TA Head.
- Partakes in the assessment of potential root cause and CAPAs associated with Significant Quality Issues.
- Contributes to the GCP QA strategy and support s QA goals for the aligned studies/countries in a given TA/Region.
- Provide inspection management support as appropriate.
- Delivers training and mentorship to less experienced QA staff.
- Strong collaboration and cross-functional leadership skills.
- Capable of working and communicating effectively with all levels of the organization globally.
- Excellent facilitation and project management skills, with strong verbal and written communication skills (including audit report writing).
- Effectively applies skills to utilize knowledge, networks and data to support rapid decision making with support of management.
- BS/BA degree (or equivalent) in relevant area with significant experience in the field and experience in the pharmaceutical industry including experience conducting a broad range of audits.
- A minimum of 3- 5 years direct experience in conducting clinical investigator site audits, clinical document audits and clinical vendor audits against global and local (country specific).
- Demonstrated application and working knowledge of EU, US and international regulatory standards and guidelines for the conduct of clinical trials.
- Basic knowledge of Vaccines clinical trials and preferred experience in Vaccines development programs.
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.
£15 - £20 per hour
Hobson Prior are looking for Quality Auditor to join a leading global biopharmaceutical company that has been inventing for life for more than a century.