Director/Associate Director, Quality Assurance

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: Responsible for quality and regulatory compliance related to GMP/GQP/QMS, Pharmaceuticals and Devices. Will ensure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. The successful candidate will be a highly motivated individual to supervise the local Quality Assurance and Control Activities for release of commercial product in Japan, and will be responsible for the day-to-day Quality Control of the Japanese operations. What You'll Do: Act as Quality Assurance Officer (Hinseki) and lead GQP/QMS activities Conduct or supervision of quality assurance activities, including but not limited to, product release, self-inspection, training, handling of defects, quality complaint and change control. Document Control and management for GQP/QMS/GDP Introduction and maintenance of Quality Systems including CSV and ER/ES within Veeva Quality and QMS Product market release in Japan Corrective Action and Preventive Action Conduct internal process audits and external supplier audits as necessary Communication and negotiation with External Suppliers and internal stakeholders Creation and Maintenance of Quality Agreements for Japan Suppliers Collaboration with Drug Safety pharmacovigilance Product Artwork review and approval Others quality assurance related tasks as Quality Assurance Officer (Hinseki) Reporting of any Quality related issue to the Marketing Supervisor General (Sokatsu) Communication with Global QA and External Suppliers Ensure the consistency between JNDA dossiers and actual operating process Manage Quality and Regulatory compliance tasks of the GMP inspections and FMA registration Correspondence with MHLW, PMDA and Tokyo Metropolitan office Lead and manage the GQP team, providing guidance and support as their people manager Who You Are: At least 5 years of QA experience in regulated industry such as pharmaceutical,biologics or device. Knowledge of ICH and GMP/GQP/QMS regulation Understanding of PMDA inspection and License inspection procedures Demonstrated understanding of the science underlying relevant diseases and its impact on the Quality process. Strong understanding of the drug development process. Demonstrated understanding of legal, regulatory and compliance policies Experience with effectively managing PMDA inspections, working with regulators, and external supplier audits. Must have good communication and presentation skills (verbal and written / Japanese and English) Must have ability to meet tight deadlines and be efficient, detail oriented, flexible, and a self-starter. Good problem solving skills including root cause analysis approaches Demonstrated knowledge with the following regulations and guidance: ICH Q10 – Pharmaceutical Quality Systems Japanese GMP for Drugs Basic knowledge of Japanese device regulations Ability to make risk-based decisions based on current laws, regulations and experience Highly organized with a strong attention to detail, clarity, accuracy and conciseness. Demonstrated experience improving, developing and implementing new processes Works effectively across functions and global environment as a team player Highly proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook). An uncompromising ethical standard and level of conduc ... (truncated, view full listing at source)