Position Summary
This position will be responsible for ensuring the implementation and maintenance of the processes required for the quality management system. in place to meet or exceed compliance with global policies and local regulatory requirements.
Key Duties and Responsibilities
- Conclude quality agreements with manufacturers involved in products that have manufacturing and marketing approval, conduct regular on-site audits, etc., and confirm that appropriate manufacturing and quality controls are implemented. In addition, the manufacturer etc. are managed by issuing improvement instructions as necessary.
- Participate the Quality related meeting with Global team and make a judgment as GQP.
- Appropriately evaluate the results of manufacturing control and quality control of final products and determine whether to ship to the market.
- Analyses information related to product quality, etc., and devise and implement countermeasures for quality improvement and recurrence prevention measures for deviations.
- Evaluation / confirmation of manufacturing method / test method change, evaluation / response of deviation events in manufacturing etc., response to authorities at the time of collection, records, various GQP-related statements.
- Appropriately manage the requirements for the preparation and storage of documents, and other requirements stipulated in the Pharmaceuticals and Medical Devices Act and related laws and regulations.
- Manage the manufacturing site information, manufacturing method, test items, other necessary items and the actual conditions at the manufacturing site so that there is no discrepancy.
- Provide appropriate leadership within global and local teams with excellent communication skill.
- Evaluation of in-licensed and developed products
- Preparation of Application form (CTD M1.2) and CTD 3
- Preparation of Application form for Medical Devices.
- Change control of approved products (preparation of submission documents for partial change application)
- Guidance, control and audit of contract manufacturing sites
- Other duties as assigned.
Desired Education, Skills and Experience
- B.S. Degree in life sciences with advanced degree in a scientific discipline preferred.
- 10+ years of leadership experience within Pharmaceutical Quality in the pharmaceutical Industry.
- 5+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC.
- Experience interfacing / working with regulatory bodies or supporting regulatory submissions (PMDA, MHLW, etc.).
- Exceptional understanding of GQP/GMP/QMS regulations, guidelines and compliance requirements.
- Practical experience in the pharmaceutical industry in commercial quality, distribution, manufacturing or QC role(s) for drugs.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Demonstrated ability to work independently with minimal supervision.
- Ability to work independently as well as collaboratively in a team environment, including liaising with multiple departments and exceptional self-management ability.
- Strong vendor management and oversight skills.
- Business level English (Writing, Reading and Speaking)
