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Responsibilities:
- Ensure risk-based quality management is applied to specific studies.
- Monitor and track quality metrics to identify trends and areas of improvement.
- Facilitate review of potential Serious Breach and Urgent Safety Measure assessments.
Required Qualifications:
- 10+ years of experience in FDA regulated industry.
- Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required.
- Strong business partner with a focus on collaborating and delivering results.
Education:
- Bachelor’s degree required.
Kailera Therapeutics
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.