Biopharmaceutical Quality Assurance Director
3 weeks ago
Our client, a pioneering organisation in the biopharmaceutical industry, is seeking a seasoned Quality Assurance professional to spearhead the development and implementation of a comprehensive Quality Assurance program. This newly created role will be instrumental in shaping the Quality Assurance function and driving cultural change within the team.
About the Role:
- Develop and maintain a Quality Assurance program ensuring compliance with GMP, regulatory standards, and internal policies for viral vector manufacturing.
- Lead, mentor, and manage the QA team, guiding them through the transition to a GMP-compliant environment and fostering a culture of quality and accountability.
- Collaborate with cross-functional teams to integrate quality processes throughout the production lifecycle.
- Manage deviations, CAPA, and change controls, ensuring timely resolution and continuous improvement.
- Conduct internal audits and manage external audits by regulatory authorities and clients, ensuring inspection readiness.
- Drive quality initiatives and promote best practices across the business.
Requirements:
- Bachelor's or Master's degree in Biological Sciences, Biotechnology, or a related field.
- At least 8 years of Quality Assurance experience in a manufacturing setting, preferably within a biological manufacturing environment.
- Strong knowledge of GMP regulations and global standards.
- Proven leadership experience and solid problem-solving skills.
- Excellent communication and interpersonal skills, with the ability to influence and drive change across teams.
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