Associate Director, Quality Assurance

As a Associate Director, Quality Assurance you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Manage and conduct clinical GCP audits of investigator sites, trial master files, databases, systems and clinical study documents such as clinical study reports and submissions in compliance with relevant Global and local regulations, ICH GCP, study procedures and policies and procedures for pharmaceuticals, biologics, and medical devices.
• Assess impact of audit findings on subject safety and protection, subject rights, data integrity, regulatory compliance and business operations.
• Apply overall audit ratings and criticality ratings for audit findings.
• Request, review and approve CAPA responses, as well as follow up and close them, as required.
• Develop and maintain the annual audit plans and audit strategy in collaboration with the Head of CQA Audit Operations and the CQA Program Managers for ongoing clinical trials using a risk based approach.
• Participate in the development of departmental standard operating procedures, work instructions, forms, and templates, as required.
• Develop and maintain the annual audit plans and audit strategy in collaboration with the Head of CQA Audit Operations and the CQA Program Managers for ongoing clinical trials using a risk based approach.
• Plan, coordinate, and conduct clinical GCP audits of investigator sites, trial master files, databases, systems and clinical study documents such as clinical study reports and submissions to assess clinical study compliance with ICH Good Clinical Practice (GCP), regulatory standards, study procedures and Takeda procedures.
• Enhance the scope of GCP audits by executing document reviews, reviewing data analytics and conducting interviews.
• Assess impact of audit findings on subject safety and protection, subject rights, data integrity, regulatory compliance and business operations.
• Apply overall audit ratings and criticality ratings for audit findings.
• Write the audit reports, document the audit findings, issue the audit reports and CAPA plans, follow up on the CAPAs, etc.
• Engage with auditees on reporting audit outcomes and recommendations.
• Request, review and approve CAPA responses, as well as follow up and close them, as required.
• Participate in the development of departmental standard operating procedures, work instructions, forms, and templates, as required.
• Escalate systemic and/or critical issues as per procedures and recommend mitigation actions to senior management for immediate and long-term effectiveness.
• Participate in GCP health authority inspections, as required.
• Mentor CQA staff (particularly in relation to the development of auditing skills) and provide support to CQA personnel, as needed.
• Participate in the quality risk management initiative and other projects, as required.

You are:

• BA/BS degree required; advanced degree preferred.
• Minimum of 10 years of experience in the pharmaceutical, biotechnology or related health care industry.
• Minimum 7 years of GCP-related Quality Assurance experience as an auditor.
• Extensive knowledge and/or awareness of ICH GCP and applicable global regulations and guidance for clinical development.
• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data integrity.
• Experience in management of GCP investigations and inspections.
• Collaborative team player with a positive attitude and ability to think and act quickly to identify creative solutions to complex problems.
• Excellent communication skills with ability to negotiate and influence without authority in a matrix environment.
• Strong judgment, project management and decision-making skills; able to manage multiple projects and demanding timelines.
• Ability to analyse complex data.
• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required.
• Requires approximately 20% travel.

 
Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.