Charles River Laboratories is seeking an experienced Site Quality Head to lead and elevate our Quality Assurance (QA) and Quality Control (QC) functions. In this pivotal role, you'll partner with Global Quality stakeholders to implement and continuously improve Quality standards across a dynamic, fast-paced environment. Your leadership will be instrumental in driving excellence in cell and gene therapy manufacturing, ensuring compliance with global regulatory standards, and fostering a culture of continuous improvement and collaboration.
Key Responsibilities:
- Lead Site Quality Operations: Oversee all QA and QC activities, ensuring site-level compliance with regulatory standards and company policies.
- Regulatory Liaison: Act as the primary Quality contact for FDA, EMA, and other regulatory agencies during audits and inspections.
- Client Partnership: Serve as the primary Quality contact for client engagements, ensuring adherence to Quality Technical Agreements (QTA) and regulatory requirements.
- Strategic Oversight: Develop and implement site-wide regulatory strategies, with authority over critical quality decisions, including lot release or rejection.
- Quality Governance: Chair the monthly Quality Management Review (QMR) and actively participate in site governance forums to drive performance improvements.
- Continuous Improvement: Sponsor site-level remediation and quality enhancement initiatives, aligning with global Quality standards.
- Team Leadership: Lead, mentor, and develop the Quality team, fostering an employee-focused culture that emphasizes professional growth, compliance, and collaboration.
Qualifications:
- Education: Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
- Experience: Minimum 10 years in biologics, pharmaceuticals, or medical devices (Cell & Gene Therapy experience highly desirable).
- Certifications: Six Sigma Green or Black Belt preferred.
- Skills:
- Strong leadership, collaboration, and project management abilities.
- Excellent verbal and written communication skills.
- Proficiency in Microsoft Office and electronic document management systems.
- High attention to detail with the ability to manage multiple priorities in a fast-paced environment.
Why Join Charles River Laboratories?
At Charles River, we are committed to Care, Lead, Own, and Collaborate. Join us in shaping the future of healthcare innovation, where your contributions will directly impact the development of life-changing therapies.
Ready to make a difference?
Apply now to be part of a global leader in advancing science and innovation.
