希少疾患に特化した外資スペシャリティ製薬メーカー

SUMMARY:
The Quality Associate Director (AD) reports to the Director of In-Market Quality and plays a key role within the External Quality organization. The AD leads and provides leadership to the JP QA team to ensure the overall responsibility, oversight, and management of quality-related activities for drug product releases to Japan and APAC region as required.

The AD’s responsibilities consist of managing the Japan QA team to direct and maintain the compliance profile and quality mindset including planning, implementation, project management and management of applicable Quality Systems. The AD will work closely with peers in a team-matrix environment to have proper oversight of all partners related to product testing and releases to Japan and APAC region.

The AD is responsible for the leadership of Quality Assurance (QA) and Quality Control (QC) activities specifically to Japan as required by GQP ordinances and the APAC region. This role interacts with partners that act as Marketing Authorization Holders of our products to accomplish Quality Technical Agreement (QTA) activities and provide QA support to Supply chain Management (SCM) related activities.

This position will be based in Tokyo, Japan and will require travel.

RESPONSIBILITIES:
The AD is responsible for leading a team to ensure required QA duties at the Japan entity are in accordance with Good Quality Practice (GQP) and Good Manufacturing Practice (GMP) for QC, secondary packaging, in-country testing and visual inspection.

Perform the duties of the Quality AD to ensure company products, procedures and policies follow the Japanese regulations, Good Quality Practices (GQP), Good Manufacturing Practices (GMP) and the company's global procedures.

These duties include, but are not limited to:
- Provide oversight and strategic guidance for Japan QA operations
- Provide operational and technical leadership to the Japan QA department through management, planning and allocation of resources
- Develop, measure, and maintain processes to ensure timely quality related activities for launch, management of outsourced activities in Japan (Testing labs and manufacturing operations)
- Provide cGMP, GQP, Quality expertise for all aspects of Quality related activities
- Coach and develop individuals within the group
- Responsible for leading development discussions with direct reports in areas of professionalism and personnel development
- Responsible for overall performance of the team in areas of routine testing to ensure samples are tested and results reported within expected timelines
- Contributes to the hiring and the performance management of the team
- Ensure all required quality assurance duty procedures are in place and approved to conform to the standards for quality assurance
- Establish GQP agreements with all ex-country manufacturers
- Ensure drug product releases conform to Japanese regulations and the Japan marketing authorization (MA)
- Promptly report to the Marketing Supervisor General and Corporate Quality Director any manufacturing, quality control, or product quality defects identified during product release evaluation
- Closely collaborate with and maintain a timely and open communication channel with other departments such as drug safety control /BPV, Regulatory Affairs and other departments to ensure product safety and quality
- Periodically verify the manufacturing and quality control of the Manufacturer’s of the drug product
- Change Management, to include ensuring that any proposed manufacturing, testing or specification change does not seriously impact the quality of the product
- Notify the Manufacturers in the event that any improvements to the manufacturing or quality control are required
- Ensure appropriate investigations are performed in the event of any product complaint or other reported product quality or safety concern
- Ensure appropriate procedures are in place for handling product recalls
- Perform self-inspections, including internal audits
- Ensure drug product shipment and storage maintains drug product quality and safety throughout the in-country supply chain
- Ensure controlled documents are approved, distributed and maintained in accordance with GQP and established quality assurance duty procedures.

*10% traveling required to partners
*This is a hybrid role based in Tokyo, Japan. Our company defines hybrid as two days onsite per week and may be subject to change as needed.

SCOPE
This position is needed to assure continuity business of Marketing Authorization Holders of Drug Product in the region that have responsibilities to follow local/APAC requirements, regardless of the responsibilities of Distribution partner.

SKILLS and KNOWLEDGE
The ideal candidate will have the following skills:
- Partner Oversight – Understand risk management and able to assess health of a partner and work with multiple partners. Experience with collaborating with partners to mitigate and improve control strategy for clinical and commercial products.
- Decision Making/Problem Solving – Identifies problems and be able to lead and handle complex situations (e.g. major investigations). Collect input from key stakeholders in making sound and effective decisions and ensure the solutions and approach are aligned within and across teams. Be decisive and move to action in the absence of clear information. Be proactive in implementing process improvements.
- Influence and Collaboration – Success in working in a matrixed organization and work with different time zones. Demonstrates effective communication and interpersonal skills that brings cross functional teams together to reach a shared goal. Possesses strong verbal and written communication skills and the ability to influence at all levels.
- Agility – Ability to pivot quickly and recover constructively from setbacks, while continually learning and modifying approach.
- Leadership - Ability to interact with and provide leaders with guidance and recommendations to assist with decision making. Ability to facilitate meetings, influence stakeholders, and manage teams effectively in projects and goals.
Quality Systems/GMP/Regulations - Working knowledge of GMP Quality Systems and cGMP Regulations (e.g., deviations, change controls, lot release, annexes).

EDUCATION
- Degree in the microbiology, biotechnology, chemistry or equivalent, in a technical discipline is required
Technical knowledge of Biologics CMC, GQP, GMP and pharmaceutical-related laws and regulations in Japan
Knowledge of GMP compliance inspection for JNDA
- General technical knowledge of GMP compliance inspection for the APAC region

EXPERIENCE
- Overall knowledge for SCM related activities, especially cold chain products
- Knowledge of JP, US and EU GMP and ICH guidelines
- Previous experience with leading teams and/or managed people
- Minimum 15+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
- Previous experience working with or liaising with the pharmaceutical and medical device agencies (PMDA and APAC region Health Authorities) and other administrative agencies preferred
- Partner oversight, risk and project management
- Demonstrated conversational English language skills
- Strong written and verbal English language skills preferred