About Jazz Pharmaceuticals

Jazz Pharmaceuticals is a global biopharma company that transforms the lives of patients and their families through innovative medicines.

We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience.

We are headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities, and employees in multiple countries committed to serving patients worldwide.

Quality Responsible Person (品質保証責任者)

The Quality Responsible Person shall manage and direct the quality affairs of Jazz Pharmaceuticals JapanK.K. to maintain marketing authorization and adhere to regulatory requirements related to quality assurance for Jazz Pharmaceuticals JapanK.K. and its products in Japan.

Essential Functions/Responsibilities

• Function as Hinseki (品質保証責任者) stipulated in GQP to support the Sanyaku (three officers in MAH) organization within the Japan office.

• Lead the preparation and execution of Quality Management activities for Japan.

• Acts as key contact person to Affiliate & In-Market QA.

• Responsible for GQP compliance management and execution of necessary actions including organization management.

• Manage and ensure oversight of the QA processes including, but not limited to, Product Release, Complaint Handling, Investigations, CAPA, Warehouse Operations and/or Stability Data Review, Validation, Change Control Management, Training and Distribution.

• Manage quality evaluation of contracted warehouse operations, manufacturing sites, and external laboratories.

• Provide support to routine activities, projects, development and training relevant to area of expertise where required.

• Support continuous improvement activities regarding areas of responsibility.

• Engaging assessment regulatory impact on product quality and manufacturing processes.

• Analyze and communicate proposed, new or changing requirements and for their implementation, ensuring business goals are met. Includes liaison with other functions, industry bodies or regulators as required.

• Engage with the Affiliates & In-Market Quality team to ensure global quality management objectives, KPI reviews, knowledge sharing, and localization requirements.

• Identify, assess and manage regulatory risk proactively and provide senior management in the MAH with key data to help drive decisions.

• Engaging site inspections, preparing audit observations response as necessary.

• Own compliance assessment and remediation plans while influencing execution, communications and training for Quality matters.

Required Knowledge, Skills, and Abilities

• Minimum 10 years of related pharmaceutical industry regulatory experience.

• At least 5 years of QA experience in a pharmaceutical manufacturing environment (at least 3 years in a supervisory or managerial role).

• In-depth knowledge of ICH requirements and Japan regulatory requirements, especially in CMC.

• Proficient with eQMS and eDMS systems.

• Ability to identify root cause of problem and creatively problem solve to gain resolution.

• Ability to prioritize and handle multiple projects simultaneously.

• Ability to negotiate and communicate with internal and external customers.

• Good sensitivity of potential risk and risk management in business compliance and quality.

• Technical transfer experience for QC test or manufacturing process for sterile products.

• Experience of CA/PA planning and execution.

• Demonstrate evidence of a professional qualification for Hinseki (品質保証責任者) stipulated in GQP:

• Experienced in the quality assurance duties or other similar duties for at least three years.

• Competence in conducting the quality assurance duties correctly and efficiently.

• Not to hinder the proper and efficient conduct of the quality assurance duties.

• In-depth knowledge of ICH requirements and Japan regulatory requirements, especially in Quality.

• Ability to identify root cause of problem and creatively problem solve to gain resolution.

• Ability to prioritize and handle multiple projects simultaneously.

• Ability to negotiate and communicate with internal and external customers.

Skills

• Ability to create Japanese QA related documents with communication skills with multiple stakeholders both internally and externally including Japanese Health Authorities.

• Demonstrated experience in effective communication.

• Strong negotiating skills and ability to think creatively and develop creative solutions.

• Native level in Japanese and sufficient English level (speaking & writing English) to achieve communication/discussion with global team is required.

• Excellent oral and written communication skills, liaising with multiple stakeholders both internally and externally including Japanese Health Authorities.

• Excellent leadership skills and ability to work in a team.

• Education Required: BS Degree in scientific disciplines, MS/PhD (preferred).

• Strong PC literacy is required; MS Office skills (Outlook, Word, Excel, PowerPoint).

Attributes

• Experience of leading Japan Health Authority interactions related to Quality Issues. (preferable)

• Experience being in Hinseki role (preferable)

Skills

• Familiar with Veeva Vault system (preferable)

• Pharmacist license (preferable)