We are seeking a highly skilled Director of Clinical Quality to lead our clinical quality program. The ideal candidate will have extensive experience in clinical quality management in the biotech or pharmaceutical industry, with a strong focus on cell and gene therapies.
- Develop and implement a comprehensive clinical quality management program for our cell and gene therapy clinical trials.
- Ensure compliance with regulatory requirements and industry standards, including FDA and EMA regulations and guidelines.
- Lead the development and implementation of clinical quality systems, policies, and procedures.
- Establish and maintain effective relationships with clinical operations, data management, and other cross-functional teams to ensure quality objectives are met.
- Develop and implement a risk-based approach to quality management, including risk assessments and mitigation plans.
- Monitor and evaluate the effectiveness of the clinical quality management program, and implement continuous improvement initiatives as necessary.
- Develop and manage clinical quality metrics and reporting, and ensure timely communication of quality-related issues to senior management and stakeholders.
- Manage and mentor a team of clinical quality professionals, providing leadership and guidance to ensure successful execution of quality objectives.
- Bachelor's degree in a scientific or healthcare-related field; advanced degree preferred.
- 6+ years of experience in clinical quality management in the biotech or pharmaceutical industry, with a strong focus on cell and gene therapies.
- Strong knowledge of FDA and EMA regulations and guidelines for clinical trials, as well as industry standards and best practices.
- Proven track record of developing and implementing effective clinical quality management programs.
- Experience with risk-based approaches to quality management.
- Strong leadership and management skills, with the ability to effectively manage a team and collaborate with cross-functional teams.
- Excellent written and verbal communication skills.
- Strong problem-solving and decision-making skills, with the ability to think creatively and strategically.
They offer a competitive salary and benefits package, as well as the opportunity to work with a talented and dedicated team in a fast-paced and dynamic environment. If you are passionate about improving patient outcomes through innovative therapies and meet the qualifications outlined above, please submit your resume and cover letter for consideration.