Clinical Quality Compliance Lead

ICON; New York (NY); Remote; USD 80,000 - 120,000; Full time

Job summary

Join a leading clinical research organization as a Clinical Quality Compliance Lead, where you'll play a pivotal role in ensuring the highest standards of quality across clinical trials. This position offers the opportunity to develop and support quality management processes, engage with cross-functional teams, and stay updated on regulatory requirements. The company fosters a diverse culture and offers competitive salaries alongside a comprehensive benefits package, including health insurance, retirement planning, and flexible benefits tailored to your needs. If you're passionate about quality in clinical research, this is the perfect opportunity to make a significant impact.

Benefits

Health Insurance

Retirement Planning

Employee Assistance Programme

Flexible Benefits

Life Assurance

Gym Discounts

Qualifications

• 5+ years in pharmaceutical or bio-pharmaceutical roles.
• 3+ years in quality management roles.

Responsibilities

• Support GCP Lessons Learned and provide training.
• Facilitate stakeholder engagement for quality consultation.

Skills

GCP Knowledge

Quality Management

Risk Management

Regulatory Compliance

Education

Bachelor's Degree in Science or Quality Management

Job description

As a Clinical Quality Compliance Lead, you will join the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Under the leadership of the Operations Quality Lead, develop, contribute, and support the facilitation, presentation, and communication of GCP Lessons Learned, GCP Cases, or other trending analysis.
• Provide training or awareness for new or established processes or guidance.
• In collaboration with the Operations Quality Lead and the Operations Quality Manager, provide consultation and support for ad hoc requests.
• Stay current with knowledge of clinical trial requirements, ICH GCP guidelines, and global regulatory requirements for the management of clinical trials.
• Facilitate and support cross-functional stakeholder engagement to ensure adequate representation for consultation towards consensus.
• Develop matrix relationships to involve process experts and conduct improvement activities.
• Become thoroughly familiar with assigned compounds and protocols.
• Support overall quality within assigned clinical trials and submissions.
• For assigned clinical trials or assets, act as the point of contact for operational-related quality consultation, escalating to QA as needed.
• Provide risk management, consultation, assessment, and recommendations for escalation of potential quality issues or trends.

You are:

• Bachelor’s degree or equivalent with a strong emphasis on science or quality management.
• Minimum of 5 years’ experience in a pharmaceutical, bio-pharmaceutical, or Contract Research Organization company, or equivalent.
• Minimum of 3 years’ experience in a quality role.
• Working knowledge of ICH GCP and other relevant regulatory/health authority experience.
• Working knowledge of Quality Management methods, systems, and procedures.
• Experience in providing quality management within Study Teams in the conduct and management of large and complex multinational clinical trials.
• Experience in managing complex and sensitive operational challenges.
• Experience in risk and issue management and in assessing non-compliance against relevant study documents, procedures, ICH GCP, and regulatory requirements.

What ICON can offer you:

Our success depends on the quality of our people. We prioritize building a diverse culture that rewards high performance and nurtures talent.

Alongside a competitive salary, ICON offers a range of benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements.
• A range of health insurance options for you and your family.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme, TELUS Health, providing 24-hour access to support professionals.
• Life assurance.
• Flexible country-specific benefits, such as childcare vouchers, bike schemes, gym discounts, travel passes, and health assessments.

Visit our careers website to learn more about working at ICON: https://careers.iconplc.com/benefits

At ICON, inclusion & belonging are core to our culture. We are committed to providing an accessible environment for all candidates and a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need a reasonable accommodation during the application process or to perform the job, please let us know through the provided form: https://careers.iconplc.com/reasonable-accommodations

Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly who we’re looking for.

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