As the Head of Commercial Operations QA, you will play a pivotal role in ensuring the highest standards of quality and compliance across all products and operations in Japan. This position involves managing quality assurance processes, compliance activities, and collaborating with internal and external partners, as well as regulatory entities like EMA, FDA, and PMDA.
業務内容:
Oversee quality assurance processes, ensuring full adherence to local and global regulations, and lead a team responsible for quality control and reliability assurance
Manage critical functions such as product release, change control, deviations, and recall procedures
Maintain relationships with regulatory bodies and key stakeholders, driving continuous improvement and operational excellence
Develop talent within your team, ensuring a strong pipeline of future leaders.
応募資格:
10+ years of experience in quality assurance within the pharmaceutical or biotech industry
Strong understanding of local and global regulatory requirements for GXP compliance
Hands-on experience with quality systems and compliance activities (GQP, GMP, GDP)
Familiarity with CMC processes, including validation and quality control testing
Experience interacting with regulatory bodies (e.g., EMA, FDA, PMDA) and managing compliance
Proven leadership skills with the ability to develop and mentor teams
Strong interpersonal skills for managing relationships with external partners and stakeholders.
