Position Summary

The Director of Quality/SW - Japan is primarily responsible for providing appropriate oversight of the site-specific Quality Management System (QMS) to ensure compliance with all applicable regulations and to ensure development of Medical Device SW(MDSW) program for Japan. The position will work in collaboration with the Laboratory Operations, Global Quality Assurance, Regulatory Affairs, Product Development, IT/Software engineering and Business Development teams to provide Quality oversight throughout the product lifecycle.

Job Responsibilities

• Assist in overseeing all QMS and SW functions for Caris Life Sciences – Japan, in harmonization with global QMS and in collaboration with Global Quality Assurance team.

• Ensure compliance to GMP’s, ISO 13485, and other regulatory agency requirements and company QMS initiatives.

• Implement Japan QMS: Write and maintain procedures relating to Japanese (MHLW Ordinance No. 169) and EU/international QMS requirements.

• Support Head of Quality, Regulatory and IT/Software Engineering to ensure compliance with international software requirements and Japan Portal development/deployment.

• Ensure technical documentation is completed to support Japan submission and approval.

• Collaborate with MHLW for the new SaMD study group established in conjunction with PMDA.

• Mentor, train, and develop Quality staff.

• Ensure the promotion of awareness of applicable quality management system requirements throughout the organization.

• Lead inspection readiness activities and provide Quality support during site inspections by regulatory agencies.

• Oversee internal and external audit programs.

• Manage Complaint, Nonconformance and CAPA programs.

• Direct risk management activities to fulfill requirements of applicable regulations and standards.

• Acquire and maintain applicable site registrations and licenses including Marketing Authorization Holder requiring formal licensing by the prefectural (regional) government (Metropolitan Gov of Tokyo), and employ qualified personnel, i.e. a General Manager, a Quality Manager, and a Safety Manager

• Assist Caris Supplier Quality with vendor qualifications activities.

• Oversee site-specific Post-Market Surveillance activities and liaise with global Regulatory Affairs for reportability determination.

• Establish Quality-related Key Performance Indicators according to global requirements.

• Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication.

• Assist, as needed, to perform other related duties and special projects as required.

Required Qualifications

• Master’s degree with a minimum five (5) years of relevant work experience, or bachelor’s degree in a scientific or related field with minimum seven (7) years of relevant work experience, or relevant comparable background.

• Extensive experience with ISO 13485 and MHLW Ordinance No. 169.

• Experience in hosting regulatory inspections.

• Understands MHLW/PMDA intent and inner workings.

• Experience in international SW requirements and understanding around Japan Portal development.

Preferred Qualifications

• MDSAP

• Excellent technical report writing skills. Preferably, experience with technical SaMD documentation for Japanese regulatory submission.

• Demonstrated success independently working with cross-functional teams.

• Strong Communication, interpersonal and problem-solving skills, and detail oriented.

• Drive for Results (Service, Quality, and Continuous Improvement) – Ensure procedures and processes are in place that lead to delivery of quality results and continually reassess their effectiveness to achieve continuous improvement.

• Communication – Proficient verbal and written communication skills. Willingness to share and receive information and ideas from all levels of the organization in order to achieve the desired results. Ability to compose clear, concise, and professional written communication.

• Teamwork – Commitment to the successful achievement of team and organizational goals through a desire to participate with and help other members of the team.

• Customer Service Focus – Demonstrate a focus on listening to and understanding client/customer needs and then delighting the client/customer by exceeding service and quality expectations.

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.

• Ability to sit for extended periods of time.

• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes, and bio-hazardous material in the lab environment.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this position.

Other

• This position requires periodic travel and some evenings, weekends and/or holidays.

Conditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.