Associate Director, QA
A rapidly expanding global biopharmaceutical company is advertising a vacancy for a Quality Assurance Associate Director position in their UK office. The organisation is dedicated to being leaders in innovative medicines and vaccines. This is an exciting opportunity to work with a dynamic and innovative company that is rapidly changing the face of the personal healthcare industry.
- Serves as the single point of contact for clinical project teams and provides Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GPVP) and/or quality advice and guidance for Vaccine studies and other Therapeutic Areas and/or counties.
- Proactively identifies, 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.
- In collaboration with the QAL, actively contributes to the quality management oversight, in the development of clinical risk assessments, quality oversight initiatives and the identification of audit substrate.
- Completing an assessment of clinical investigator sites, vendors, study activities, clinical study reports and submission documents.
- 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. Participates in the assessment of potential root cause and CAPAs associated with Significant Quality Issues.
- May manage personnel or assist with the management of personnel and planning functional group activities to achieve functional area and/or departmental objectives.
- Provide inspection management support as appropriate.
- Provides training and mentorship to less experienced QA staff.
Skills and Requirements
- 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.
- Minimum 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 ideally and preferred experience in Vaccines development programs
- Effectively partners with others to accomplish quality goals.
- Demonstrates advanced communication skills to convey and receive information.
- Demonstrates advanced oral and written communication skills.
- Effectively applies skills to drive or participate in change efforts to enhance our Research & Development Division to improve quality to the business.
- Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites & functions.
- 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.
- Ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Katty Maia on +44 203 854 3317 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.