Senior Quality Leader
3 weeks ago
The Senior Quality Leader will provide strategic leadership for all Quality functions and report directly to the CEO. This role will focus on developing and maintaining best-in-class Quality Control and Quality Assurance teams. The Senior Quality Leader will be based in the US and will sit on the senior leadership team.
Key Responsibilities:
- Develop, implement, and oversee a comprehensive quality strategy and roadmap aligned with Company goals and growth objectives.
- Lead, manage, and develop the Quality Control and Quality Assurance teams to deliver high performance and efficiency to meet company goals.
- Ensure productive quality management systems, processes, and procedures aligned with compliance and risk best practices.
- Partner with cross-functional teams to ensure quality best practices and procedures are embedded in all GDMP and R&D activities.
- Conduct risk assessments and audits and advise on necessary improvements and adjustments as needed.
- Serve as the primary point of contact for quality-related matters for internal and external parties.
Requirements:
- 10+ years of experience as a senior Quality Leader with extensive professional understanding of both Quality Control and Quality Assurance best practices.
- Deep understanding of GMP, quality systems, and regulatory best practices from early-stage clinical development through commercial approval.
- Extensive experience as a strategic leader with ability to lead, develop, and grow teams.
- Experience at a growth stage company with the ability to be both a strategic and a hands-on leader.
- Strong communication skills and ability to connect with internal and external stakeholders.
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