Director, Quality Assurance

3 weeks ago


Boston, Massachusetts, United States ICON Clinical Research Full time
Job Title: Director, Quality Assurance

About the Role:

We are seeking a highly skilled Director, Quality Assurance to join our team at ICON Clinical Research. As a Director, Quality Assurance, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of innovative treatments and therapies.

Key Responsibilities:

* Leading the development and implementation of quality assurance strategies and processes to support clinical trial activities.
* Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.
* Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.
* Providing expert guidance and support to staff regarding quality assurance policies, procedures, and best practices.
* Contributing to the continuous improvement of quality management systems and documentation.
* Developing, implementing, and maintaining an ISO 13485-compliant Quality Management System, QA activities, processes, and associated policies and SOPs, that meets regulatory obligations and supports business objectives.

Requirements:

* Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
* Minimum of 5+ years of experience in quality assurance within the pharmaceutical, biotechnology, or CRO industry, with significant experience in a leadership role.
* Extensive knowledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
* Strong analytical and problem-solving skills, with the ability to identify and resolve complex quality issues.
* Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.

What We Offer:

* Competitive salary range: $143,944.00-$179,930.00
* Bonus, stock compensation, and commissions in some cases depending on role and performance
* Comprehensive benefits package, including health insurance, retirement planning, and employee assistance program
* Opportunities for professional growth and development

About ICON Clinical Research:

At ICON Clinical Research, we are committed to providing an inclusive and accessible environment for all candidates. We are proud of our diverse workforce and the work we've done to become a more inclusive organization. We are dedicated to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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