Head of Quality Assurance (London OR Home Based)

Head of Quality Assurance

Global Oncology Site Network

London Office OR Home based

Introduction

At ICON, it's our people that set us apart.

Are you looking for an outstanding opportunity to develop your career with a leading edge Global Commercial Oncology Site Network which is growing fast?

Our Oncology Site Network concentrates on fast site set up, quick patient enrolment, high data and quality standards, delivering excellent patient experience resulting in a high level of patient retention. These qualities are what our Sponsors look for in a leading Oncology Site Network and you can be part of our success story. We are growing our international footprint and you can play a part in our expansion and be involved in the future of oncology treatments across the globe.

This is an excellent opportunity for a Head of Quality Assurance with exposure to research sites and networks to play an important role in driving our organisation towards success.

As Head of Quality Assurance you will lead the Quality function of the Company including Quality Control and Quality Assurance. You will work to ensure that the company is always "Inspection Ready" and that Sponsor and Regulatory Audits result in positive outcomes.

Main responsibilities:

• To ensure Quality assurance oversight of all Company activities.
• To ensure that customer service delivers to and aims to exceed customers' Quality Assurance expectations and metrics.
• To ensure that there is a quality and regulatory compliant working environment and best practices are achieved.
• To develop the Quality teams' effectiveness through leadership, coaching and performance management.
• To ensure compliance with mandatory training and all regulatory requirements in the conduct of clinical trials.
• To ensure that the company is "Inspection Ready at all times and that Sponsor and Regulatory audits are undertaken professionally and result in positive outcomes for the company.

• To be part of the management team and work with all ICON Oncology Site Network staff to ensure a culture of high quality and to develop a commercially successful oncology research organisation.
• To work with Oncology Site Network personnel to improve and implement globally working practices and systems, in compliance with GCP and appropriate regulations to ensure best practices are achieved.

Key Accountabilities

• Lead and develop the Quality Team across the organisation ensuring team members have clear direction and accountabilities that meet business requirements.
• Responsible for the implementation, update and maintenance of the Oncology Site Network quality control processes and management of a quality monitoring system.
• Ensure standardisation of QA activities, across the international company including implementation of annual global internal audit plan and Quality Control processes.
• Responsibility for providing support for external audit preparation and conduct at Sites and Central functions.
• In conjunction with sites, manage and support sites with all aspects of regulatory and sponsor inspections to achieve positive outcomes.
• Lead Quality function to meet international standards through a robust CAPA and continuous improvement process.
• Ensure compliance with company quality framework, regulatory (GCP) legislation, guidelines and international standards.
• As required, work with Business Development to provide quality reviews in advance of client meetings and attend client meetings with BD to represent Quality Assurance view.
• To ensure knowledge with regards to quality best practice requirements is kept up to date through reading and attending relevant forums.
• Travel approximately 30%.

To be successful you will need:

• Qualifications

• BSc degree (life science) or equivalent qualification

• Experience

• Demonstrable experience within a Clinical Quality Assurance role, working within a Site Network, CRO or Pharma organisation
• Experience of devising and implementing policies, providing compliance advice and training
• Extensive knowledge of managing, maintaining and improving quality systems and procedures
• Significant experience of performing international clinical quality audits e.g. investigator site audits, vendor audits
• Experience of analysing data using Quality Metrics
• Previous experience in providing expert Quality Assurance advice, support and guidance to all sites including international affiliate sites
• Proven history of preparing, hosting and managing regulatory inspections e.g. MHRA, FDA including the training of staff and preparation of inspection responses
• Extensive experience in co-ordinating and hosting sponsor/CRO audits
• Knowledge of international GCP regulations and regulatory inspections
• Proven leadership of Quality Assurance initiatives and clinical governance activities

Why join us?

Ongoing development is vital to us, and as a Head of Quality Assurance in our Global Oncology Site Network, you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment