Position summary
Provide leadership and oversight as the Quality Assurance Responsible Person mandated by the Pharmaceuticals and Medical Devices Act, ensuring continued compliance with regulatory requirements and the maintenance of the company's pharmaceutical business license.
Key accountabilities
- Implement and ensure compliance to the QA processes for medical product in Japan, in compliance with the local regulations/ standards; Global QA registration/ standards; and policies/ procedure at a local, regional and global level
- Developing, promoting and auditing quality assurance processes and practices, ensuring the Group’s internal standards are met and the highest possible external inspection ratings are achieved.
- Developing continuous quality improvement methodologies and innovative quality assurance offerings that will add value in revenue growth and that will deliver excellence to clients, exceeding commercial and compliance requirements.
- Meeting all requirements and carrying out all duties expected of the statutory titles held. Ensure appropriate liaison with Medical Affairs, Regulatory, Supply Chain, Quality, Commercial, Legal, etc., to ensure Quality Assurance input into the company's strategic planning for products through their lifecycle.
- Communicate Quality Assurance concerns with or provide feedback regarding QA activities in Japan to the General marketing compliance officer and Global QA management.
Major Tasks & Activities:
Essential Duties and Responsibilities.
- Legally stipulated Quality Assurance Manager
- In the capacity of Quality Assurance Manager have an oversight of all QA activities as per applicable local legislation.
- Ensure adequate understanding of audit and inspection preparation and readiness. Give necessary instructions to each department of the company.
- Ensure understanding of the CAPA (Corrective and Preventive Actions) process. Responsible for performing CAPA activities as per identified roles.
- Ensure compliance with document management procedures for retention and archiving.
- Understand and implement the document change management process and act as SME (Subject Matter Expert) for procedures.
- Ensure all training requirements for the role are met.
- Identify appropriate stakeholders and ensure they are trained on QA requirements/ procedures.
- Build alignment and collaboration with Regulatory Affairs, Medical Affairs, Supply Chain, PV, and Commercial.
- Communicate effectively all relevant QA related compliance concerns with the Global QA management.
- Ensure adherence and appropriate implementation of the BCP (Business Continuity Plan) With regards to third party agreements
- Ensure the appropriate QA language is incorporated into 3rd party agreements. Perform regular review of the agreements to ensure QA requirements are aligned to the current regulation requirements and perform reconciliation of data between third parties and the company
- Respond to submission related queries from the regulatory authorities and archive all regulatory related correspondence.
- Oversee and monitor the transfer of product licenses to and from the company to assure data integrity and continued compliance with regulatory requirements.
Team management
- Establish and monitor budgets and forecasts.
- Manage and support of QA personnel.
- People hiring, coaching and development of new QA personnel.
- Provide feedback and regular reporting QA activities to the General marketing compliance officer and Global QA management.
- As required, participate in JAPAC meeting or other meeting as the Japan function head and collaborate with applicable departments.
Vendor/Third party Management
- To verify that the service provider is qualified to perform the outsourced QA activities prior the service starts.
- To write the Service Agreement (SA) and or QA Agreement as per JAPAC and Japan requirements.
- Maintain close contact with the Person Responsible for Implementation of QA at the contractor company for keeping outsourced work properly and smoothly.
- To monitor whether outsourced QA activities are performed in compliance with the contract requirements and KPIs by quarterly meetings.
- If the implementation of QA activities outsourced needs to be improved, instruct the contractor to take necessary actions.
- Understanding of QA vendor service standards and requirements – ability to develop and monitor key performance indicators
Requirements
- At least 10 years of QA work experience in the pharmaceutical industry. (Mandatory)
- Extensive knowledge of QA including international aspects.
- Bachelor's degree in biology or chemistry or other life sciences
- Confidence in dealing with senior management and employees at all levels, especially with the ability to work and make decisions autonomously.
- Experience working with QA databases and Microsoft Office software
- Native-level Japanese and full professional proficiency in English