Clinical Quality Assurance Director
3 weeks ago
Lantheus Medical Imaging Inc is a leading company in the field of medical imaging, with a strong commitment to quality and compliance. We are seeking a highly skilled Clinical Quality Assurance Director to join our team.
The successful candidate will be responsible for overseeing the execution and performance of our quality system elements, including GCP audit programs, continuous improvement, and quality system procedural documents. They will also interface with internal and external customers to assess and support compliance with ICH-GCP, cGLP, applicable regulations, and global quality standards.
Key Responsibilities:
- Lead the conduct of mock regulatory inspections and related activities.
- Provide inspection preparation training to internal staff, clinical investigator sites, and vendors.
- Serve as the CQA lead for assigned trials and assigned compliance areas.
- Develop and execute a risk-based clinical quality audit plan for assigned programs.
- Audit internal processes, clinical investigator sites, and vendors to assess compliance with applicable regulations/guidelines.
- Analyze and trend audit observations, gaps, and systematic issues to support continuous improvement.
- Evaluate adequacy and completeness of CAPAs originated from audits, deviations, and/or inspections.
- Author audit reports and coordinate supporting documentation.
Requirements:
- Bachelor's degree in a scientific discipline with 10+ years' experience in the pharmaceutical or biotech industry and GCP Clinical Quality Assurance.
- Experience leading regulatory inspection readiness/preparation activities.
- Full understanding of ICH GCP and applicable CFR regulations.
- Experience in risk-based quality management systems and quality by design in Phase I thru IV clinical trials.
- Ability to manage processes with a continuous improvement approach.
- Analytical and critical thinking skills.
Lantheus Medical Imaging Inc is an equal employment opportunity employer and welcomes applications from diverse candidates. We are committed to creating a dynamic and inclusive work environment that supports the success of our employees.
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