ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
The Clinical Quality Compliance Leadwill be responsible for ensuring the effective implementation and maintenance of quality strategies related to Medical groups (Medical Units and Affiliates) throughout the entire life cycle of our products, from first-in-human administration through clinical development and commercialization, including setting up strategies for determining audit needs.
This role involves proactive oversight of processes, quality risk management, and continuous improvement initiatives to ensure compliance with regulatory standards and industry best practices.
This role requires familiarity with the Early Access process, including Company Initiated Early Access Programs and Ad Hoc Single Patient Use, Investigator Sponsored Studies (ISS) as well as with PDCS (Patient Data Collection Systems), PSP (Patient Support Programs), and Access to Approved Medication for Unapproved Uses.
What you will be doing:
- Monitors and reviews audit activities, establishes risk based audit strategy to identify audit targets.
Act as QA Point of Contact for consultation for client Medical groups: Develops SME expertise in areas of responsibility of the Medical groups, supports on inspection preparation activities.
Maintain proactive oversight on the execution and quality of processes through the implementation of dedicated KPIs and metrics.
Ensure oversight on all medical activities to demonstrate adhere to relevant regulations and guidelines throughout the product life cycle.
Establish and implement risk-based strategies to identify signals, trends, risks, and gaps within the areas of responsibility. Oversee the implementation of the mitigation plans.
Identify and drive continuous quality process improvements based on audits, inspections, trends, metrics, and root cause analysis.
Collaborate with senior management and cross-functional business partners to identify compliance risks and facilitate process improvements, driving issue resolution.
Ensure rapid communication of quality issues, including potential misconduct or significant deviations, to business partners and senior management.
Provide guidance and training on relevant GxP regulations and g guidelines to cross-functional teams.
Create and maintain a network that aligns Quality activities with Medical, Regulatory, and Pharmacovigilance (PV) strategies across various regions.
Pharmacovigilance (PV) Quality Oversight:
Implement, and maintain a comprehensive worldwide Quality and Compliance risk-based strategy for pharmacovigilance processes, ensuring compliance with global regulations and guidelines.
Identify, develop, and implement quality improvement initiatives within the pharmacovigilance domain.
Medical Affairs Quality Oversight:
Implement, and maintain a quality strategy for effective oversight of Medical Affairs activities at both global and local levels, ensuring compliance with health authority regulations.
Ensure compliance oversight with regulatory requirements for key activities like: investigator-initiated studies, compassionate use programs, market access programs and other medical activities.
Implement quality assurance processes for medical information systems and databases.
Subsidiary Quality Oversight:
Implement, and execute a worldwide quality strategy for GCP/GVP regulated activities at local levels, to ensure compliance throughout the product lifecycle.
Provide training and support to subsidiary quality teams to enhance compliance and quality practices.
Regulatory Affairs Quality Oversight:
Implement, and execute a worldwide quality strategy for Regulatory Affairs activities, ensuring compliance with relevant regulations and guidelines.
Provide training and support to Regulatory Affairs quality teams to enhance compliance and quality practices.
You are:
- Education: Advanced degree in a relevant scientific discipline (e.g., pharmacy, medicine, or life sciences).
- Experience: Minimum 10 years of relevant experience in the pharmaceutical and/or biotech industry. Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance including those related to Auditing, Risk-Based Quality Assurance and Root Cause
- Analysis. Proven ability to function autonomously at a senior level in a matrix model and in a team environment.
- Regulatory Knowledge: In-depth knowledge of the drug development process, international regulations including post marketing studies.
Skills & Competencies
Leadership: Ability to lead and influence cross-functional teams to achieve quality objectives.
Communication: Proficiency in English with strong verbal and written communication skills, with the ability to convey complex quality concepts to diverse audiences.
Analytical Thinking: Strong analytical and problem-solving skills, with the ability to assess and address quality-related challenges.
What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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 or submit a request here.
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.
