※Applicants must have permission to work in Japan and required fluent ~ native level Japanese.
Lead directly members who manage the interface and performance of CMOs over which Company does not have direct control. This requires a high focus on influencing, building good relationships with key individuals, handling well pressure and resourcing to contractual requirements when necessary.
Accountable for delivery of NPI with the Supplier Relation Team and is required to resolve technical and regulatory issues, supporting the Quality Managers when requiring advanced knowledge and experience.
Run/Support the Product Incident Recall Committees within designated CMO / product portfolio. Responsible for ensuring root cause analysis is performed and appropriate recall decisions proposed in line with Company regulatory and quality expectations.
Ensure there are investigations into significant quality incidents arising at suppliers and ensure root cause of the problem is identified and appropriate corrective and preventative actions are implemented.
Ensure there is appropriate communication, cascading of information, prompt escalation of significant issues or risks across the organization, driving prompt resolution of issues. Drive periodic review of quality systems at CMOs.
Implement Quality Systems performance management with appropriate Key Performance Indicators. Track and provide supplier performance feedback to drive continuous improvement through the team.
Ensure that CMO facilities and systems meet and maintain current regulatory requirements & expectations and report all potential and actual cGMP/Regulatory compliance issues. Ensure approved Quality Agreements are in place for assigned CMOs.
Ensure there is appropriate application of risk management by identifying potential short comings in supplier's quality systems, considering the risk to patient safety and efficacy, product integrity, regulatory compliance and Company business.
Review and respond to CMO regulatory inspections on matters that involve activities related to Company products. Assess impact of inspection and External Supplier responses to Regulatory observations prior to submission to associated agency.
- Project Management skills.
- Prior experience auditing either external or internal groups.
- Operational Excellence exposure.
- A range of experience in various Technical and Quality Assurance roles across multiple product categories.
- Breadth of knowledge and experience applying cGMPs and other regulations/guidance with an ability to interpret those in a fast-paced environment.
- Good knowledge and demonstrated application of Quality and Risk Management principles.
- BSc/BEng in a Science or Engineering discipline and at least 5 -7 years experiences; OR Masters or PhD and at least 3 -5 years experiences ; AND/OR equivalency in education and experience.
- Business English (at least intermediate) TC with global stake holders, e-mail, etc
- Native Level Japanese
[Preferred Knowledge, Skills and Abilities]
- Working experience in foreign capital group on Quality Assurance roles
- Line Management experience desirable.
- Previous assignment experience promoting or requiring global perspective desirable.
- Broad and thorough technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques/ processes.
- Business English (advanced)
※Experiences and skills will be considered
Please click "apply" if you are interested in the job.
We will review your profile and contact you within five business days should we find that you satisfy the requirements of the hiring company.
Further details about the company and position will be notified at a later date.