Site Quality Head Opportunity in Top Biotechnology Organization
Summary :
Are you a seasoned quality leader seeking an exciting opportunity? Join a top-tier Biotechnology leader in New Hampshire as Site Quality Head.
Lead their quality organization at the site for C>, lead and support Audits and Regulatory Inspections at the site, and lead, develop and direct staff in both QA and QC.
Responsbilities
- Provide strategic leadership and management for the asset Quality organization.
- Ensure teamwork, high morale, and innovation are fundamental components of the team.
- Develop and execute the Quality strategy aligned with the overall plan for the company.
- Implement continuous improvement initiatives to drive Quality programs.
- Develop, implement, and monitor Quality programs, policies, and procedures to ensure compliance with GMP standards.
- Serve as the point person with industry partners regarding product quality matters.
- Oversee all partner and regulatory authority audits and inspections.
- Evaluate and recommend appropriate enhancements to current Quality systems and processes.
- Create active training and development plans for Quality staff.
- Establish and maintain positive working relationships with customers, FDA, and other regulatory authorities.
- Provide solid, well-informed, actionable Quality support to Operations, R&T, and other functions.
- Be a member of the Site Leadership team.
Requirements :
- Bachelor’s Degree in Life Sciences, Engineering, or Quality Management or related discipline.
- 10+ years of direct professional experience in GMP manufacturing and Quality Management.
- Previous experience as a Site Quality Head
- Experience in aseptic processing
- Expert knowledge of GxP, ISO Standards, FDA, and EMA regulatory requirements related to Cell / Gene / Viral therapy products
- Strong knowledge of current industry trends and technologies.
- Working knowledge of aseptic practices, clean room design / operations, and auditing techniques.
- Excellent organizational and computer software skills.
This role is only available for US Citizens or green card holders
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