Pharmaceuticals & Medical Devices (Healthcare & Medical)
Full time
Our client is a newly established organisation looking to build a world-class team to deliver cutting-edge solutions to the biopharmaceutical industry. This newly created role is a unique opportunity to join a growing company at a pivotal stage and make a significant impact on their future success.
About the role:
This newly created QA Manager role will be instrumental in shaping and leading the Quality Assurance function. The ideal candidate will not only bring strong technical expertise in biological manufacturing but will also be an influential leader capable of driving cultural change within the team. This role is critical in establishing a strong quality mindset across the organisation and ensuring that all products meet the highest GMP standards.
Your key responsibilities will include but will not be limited to:
Developing, implementing, and maintaining a comprehensive Quality Assurance program, ensuring compliance with GMP, regulatory standards, and internal policies for viral vector manufacturing. Leading, mentoring, and managing the QA team, guiding them through the transition to a GMP-compliant environment and fostering a culture of quality and accountability. Collaborating with cross-functional teams, including Manufacturing, QC, and Process Development, to integrate quality processes throughout the production lifecycle. Managing deviations, CAPA (Corrective and Preventive Actions), and change controls, ensuring timely resolution and continuous improvement. Conducting internal audits and managing external audits by regulatory authorities and clients, ensuring inspection readiness in collaboration with the Chief Quality Officer. Serving as a change agent within the organisation, driving quality initiatives and promoting best practices across the business. Staying current on industry trends, regulatory updates, and advancements to support continuous improvement. To be considered for this role, you will have the following qualifications and skills:
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 (FDA, EMA, etc.). Proven leadership experience and solid problem-solving skills. Excellent communication and interpersonal skills, with the ability to influence and drive change across teams. Ability to thrive in a fast-paced environment and manage multiple priorities effectively. #J-18808-Ljbffr