This intelligent CRO provides solutions to clinical trial services through therapeutic focus and operational proficiency for biopharmaceutical and medical device organizations and boasts expertise in areas including quality assurance, regulatory affairs, medical affairs and pharmacovigilance to name but a few.
As QA Associate Director you will perform quality assurance activities and audits ensuring compliance with laws, regulations, standard operating procedures, protocols and guidelines.
Key Responsibilities:
• Providing QA leadership, ensuring adequate QA resource is available in your designated region to cover auditing and process improvement activities and line managing QA personnel within your region identifying any training requirements
• Maintaining and managing the global QA system its effectiveness and the quality of deliverables
• Reviewing policies, SOP’s, working guidelines and other relevant documents
• Managing the global audit strategy and QA function, reviewing QA processes and associated documents and organizing and assisting in audits across global functions
• Remaining compliant with the global audit schedule and providing signatory approval audit plans, reports and certificates
• Assisting in documenting audit activities, metrics, findings and resolutions ensuring any compliance issues are raised
• Training of less experienced QA personnel on ICH, GCP and FDA regulations and supervising European contract auditors
• Managing sponsor audits and regulatory inspections, providing QA consultancy and assisting with business planning activities and business development
Ideally you will possess a life science or healthcare degree, have 7 years experience of European QA and ICH GCP auditing, 2 years process and systems auditing experience, 2 years management experience and exceptional knowledge of ICH GCP and FDA regulations. Prior experience of sponsor audits, regulatory inspections and paper based management systems would be beneficial. You should have excellent English written and communication skills, be organized, interpersonal and accurate with outstanding attention to detail, proven problem solving skills and capability to work well as a team and individually. The role will require investigation and analyses of information, the ability to develop and present training programs and a willingness to travel.
This is an outstanding opportunity within a career driven social company offering excellent benefits including competitive salaries, a pension scheme, a generous holiday entitlement, private healthcare, life assurance, flexible working hours, gym membership, a vitality scheme and extensive training opportunities to suit individual needs.
Key Words – Quality Assurance, QA, Associate Director, CRO, Clinical Research Organization, Compliance, Biopharmaceutical, Healthcare, Medical Devices, Wokingham
For further information on the role or company please contact myself, Amie Adams at Paramount Recruitment on 0121 616 3473.
Paramount Recruitment Limited provides services as an agency and an employment business. We regularly have similar roles in this area. Please see our website for details or send your CV in to us to find out the latest opportunities.
