Quality Assurance Manager

Vor 2 Tagen


Sydney, Österreich On Q Recruitment Vollzeit

On Q Recruitment is proud to exclusively partner with Viral Vector Manufacturing Facility (VVMF) to help build their quality function team.
As the organisation builds a world-class facility to deliver cutting-edge viral vector manufacturing solutions to the biopharmaceutical industry, they are currently seeking a  Quality Assurance Manager  to join their growing team.
About the role:     Reporting to the Chief Quality Officer, you will be instrumental in shaping and leading the Quality Assurance function.
You will not only bring your strong manufacturing quality assurance background 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 VVMF 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 manage 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 io 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 sterile manufacturing setting.
Experience wit biological products is ideal and not necessary.
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.
For a confidential conversation about the role, please email  Grace Bitodi at ******.



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