A leading biometrics CRO, supporting global pharma, biotech, medical device and animal health partners with innovative clinical development services, is currently recruiting a QA Manager.
Management of the quality system processes and procedures and the Quality Assurance team
- Managing departmental objectives and budget.
- Managing a risk based internal audit system and continually review and develop appropriate metrics for QA annual Trend Analysis including tracking and trending of CAPAs.
- Managing the risk-based service provider audit programme and perform key service provider audits as required.
- Planning, co-ordinating and following-up on the internal and external audits undertaken by the auditing team.
- Managing and host regulatory authority inspections and sponsor audits by the Quality Assurance team.
- Managing the QA team workloads.
- Undertaking team appraisals.
- Providing operational staff with expert advice and support in relation to good quality practice regulations and guidelines and process knowledge.
- Developing, organising and providing quality management and regulatory training for all staff, consultants and where required Sponsors.
- Responsible for the management of SQN-Clinical eQMS (Q-Pulse) system
- Deputises for the archivist as required.
Management of the quality system design, controls and continuous improvement programme
- Leading, developing and executing company strategy and operating structure for all quality and regulatory matters in relation to the principles of Good Clinical Practice.
- Driving quality and compliance infrastructure development to ensure appropriate policies, procedures and best practices are in place.
- Delivering a multi-year strategy within quality management to ensure competitive advantage and continuous improvement.
- Facilitating business relationships with internal stakeholders at all levels.
- Partnering with colleagues to proactively identify and mitigate risks.
- Managing and providing Quality Assurance consultancy as required.
Skills & Requirements:
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 Steven Fuller at +44 203 854 2630 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.