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Quality Assurance Manager
Il y a 2 mois
Overview
Cellectis is seeking a highly skilled and experienced professional to join our team as a Quality Assurance Manager, CMC Development. This role will be responsible for leading the development and implementation of quality management systems, ensuring compliance with regulatory requirements, and driving process improvements.
Key Responsibilities
- Quality Management
- Develop and implement quality management systems to ensure compliance with regulatory requirements.
- Conduct regular audits and assessments to identify areas for improvement.
- Implement corrective actions to address any deviations or non-conformities.
- CMC Development
- Lead the development of CMC (Chemistry, Manufacturing, and Controls) strategies for Cellectis products.
- Collaborate with cross-functional teams to ensure CMC development aligns with business objectives.
- Develop and maintain CMC documentation, including product specifications, manufacturing procedures, and quality control protocols.
- Regulatory Affairs
- Ensure compliance with regulatory requirements, including FDA, EMA, and other global regulatory agencies.
- Develop and maintain relationships with regulatory agencies to stay informed about changing regulations and guidelines.
- Provide regulatory guidance and support to cross-functional teams.
- Process Improvement
- Identify areas for process improvement and develop strategies to implement changes.
- Collaborate with cross-functional teams to implement process improvements.
- Monitor and evaluate the effectiveness of process improvements.
Requirements
- Education
- Master's degree, PhD, or PharmD in a life science or related field.
- Experience
- 5+ years of experience in quality assurance, CMC development, or regulatory affairs.
- Proven track record of leading quality management systems and process improvements.
- Skills
- Strong understanding of quality management systems, CMC development, and regulatory affairs.
- Excellent communication and leadership skills.
- Ability to work independently and collaboratively as part of a cross-functional team.
What We Offer
- Competitive Compensation and Benefits
- Market-competitive salary and benefits package.
- Opportunities for Growth and Development
- Professional development opportunities to enhance skills and knowledge.
- Collaborative Work Environment
- Collaborative and dynamic work environment with a team of experienced professionals.