Senior Clinical Quality Assurance Manager
- Experience Level
Our client is a rapidly growing CRO with an enviable pipeline of work for 2021. They seek a Clinical Quality Assurance Manager who will undertake CQA activities, support GCP and Clinical Trial obligations, and develop the QA department.
The ideal candidate will be an independent and self-motivated professional, with leadership, presentation and motivational skills, and the ability to lead by example, encouraging colleagues to innovate and seek solutions independently.
Success in this role will mean that planning, coordination and control of processes and methods are established, to control the quality of studies. Therefore the post holder must be proactive in developing and implementing procedures, working with a high degree of autonomy, and able to organize workload to ensure that objectives and deadlines are met.
The role is part of the Senior Leadership Team, works closely with the Clinical Operation and Information Technology teams, and reports in to the Managing Director.
• Develop and maintain GCP/ICH compliant processes which control the quality of work and clinical trials
• Actively lead in the areas of Internal Quality Audits, CAPA, Quality Management Reviews and Quality Audits.
• Lead the organization during regulatory agencies and sponsor/client audits.
• Responsible for management of contract auditors.
• Lead with identifying non-conformances against requirements, provide suitable recommendations, and facilitate ongoing improvements using risk-based methodology while maintaining compliance with applicable study protocols, Quality System Regulations and or ISO standards.
• Conducting vendor audits and work with vendors and service delivery personnel in eliminating problems via root cause analysis techniques, to ensure that service delivery continuously improves.
• Prepare, review, and approve external and internal QA reports and other documentation required by regulatory agencies, or clients.
• Update and maintain CQA Standard Operating Procedures (SOPs) that support the Quality System, manage and maintain databases for the quality system.
• Prepare and assist in preparing annual reports and quality trending reports.
• Keep up to date with all related quality legislation and compliance issues.
• Sit on the Senior Leadership team and contribute to operational excellence initiatives, both in the department and companywide, which result in the overall improvement in both areas.
Required Knowledge and Skills:
• Minimum degree (BSc) in Life Science or related discipline.
• 5 years + of demonstrated CQA experience in pharma, biotech or CRO.
• Full understanding of ICH/FDA GCP guidelines, with extensive knowledge of GCP.
• Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 for GCP
• Understanding of device regulations, development processes and FDA / EMA inspection procedures.
• Experience with effectively managing FDA / EMA inspections, working with regulators and customer audits.
• Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs.
This vacancy comes at an exciting time in the company’s growth and offers lots of scope to evolve as the business grows and diversified further. The role will be a mix of home working and office time in Hertfordshire. If you are interested in this position and would like to find out more, please get in touch for more information. You can contact Katie Dunbar on +44 (0) 1293 584 300, and either send your CV through to email@example.com or use the apply button on this page.