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Job Description

OBJECTIVES:

• Leads the Clinical Quality Assurance (CQA) function in Japan. Provides sponsor quality oversight of clinical development activities in Japan, ensuring that proactive quality risk management and risk based GCP audits are conducted, communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective actions are implemented.

• Serves as a senior strategic GCP resource to Takeda for its drug development activities, and takes a lead role for the preparation, conduct, and responses to health authority inspections of Takeda’s development activities.

• This position provides regional leadership and strategy in line with global strategic objectives. Collaborates with R&D Quality, Global Quality, R&D operational functions, and suppliers of outsourced services to ensure that clinical trial activities sponsored by Takeda are conducted in compliance with local regulations, Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda requirements.

ACCOUNTABILITIES:

• Leads and manages the Japan CQA function in the development, implementation, and refinement of processes to ensure Takeda maintains sponsor oversight of the quality of its research and development activities in compliance with applicable regulatory requirements.

• Collaborates with the other Heads of Therapeutic Area and Regions to develop and execute the strategy for sponsor quality oversight of development activities in Japan. This includes proactive and reactive compliance activities such as provision of compliance advice, review of protocols and monitoring plans, review of protocol deviation listings, review of risk and issue logs including mitigation plans, execution of audits, investigation of deviations, closure of CAPAs, management of submission readiness and inspection readiness, management of inspections and closure of CAPAs.

• Analyzes audit, deviation and inspection metrics to identify risks and evaluate the state of GCP compliance; presents analyses to TDC Japan leadership and Quality leadership and provides guidance for key stakeholders to make critical decisions.

• This position has responsibility for the CQA hiring, ongoing development and operational success of the CQA function in Japan, including talent development and succession planning, resourcing and budgeting.

• Provides leadership for investigation of critical compliance issues (scientific misconduct, significant GxP noncompliance and serious GCP breach) and escalates as appropriate to internal and external partners including regulators, as appropriate.

• Escalates systemic problems and appropriate recommendations/solutions to senior leadership for immediate and long-term resolution across Takeda R&D.

• Provides strategic direction and manages health authority GCP sponsor and investigator routine and pre-approval inspection readiness, conduct, and follow-up activities for development programs in Japan, ensuring that GCP inspection commitments are fulfilled on time.

• Collaborates with CQA Supplier Quality to determine acceptability of vendors for potential use by Takeda R&D as well ongoing evaluation of overall compliance performance of vendors.

• Ensures strong alignment with other R&D Quality and relevant R&D functions.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS :

• BS/BA Degree required; advanced degree preferred

• Expert knowledge of GCP and understanding of Japan local and global clinical development required

• Minimum 12 years of industry experience in Clinical Quality Assurance and/or Clinical Operations; advanced experience in GCP auditing required

• Minimum 7 years managing teams in a matrix team environment or managing people

• Experience working within complex and matrix organizations

• Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to patient safety and data integrity

• Ability to collaborate with and achieve results through others; builds strong and sustainable relationships and interact within all levels of the organization

• Possess outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative

• Ensures that every employee knows what is expected of their role and what it takes to be successful. Helps employees grow through challenging assignments so they may realize their full potential

• Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues

• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents. Ability to effectively present information to senior management, internal stakeholders, and external partners

• Ability to manage assignments and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines

• Excellent communicator with strong written and verbal presentation skills

• Basic level in Japanese and excellent level of verbal/written English

LICENSES/CERTIFICATIONS:

• RQAP-GCP registration/certification preferred

PHYSICAL DEMANDS :

• Routine demands of an office-based environment (Osaka)

TRAVEL REQUIREMENTS:

• Approximately 20-30% domestic and international travel

• Willingness to travel to various meetings and/or audits, including overnight trips. Some international travel may be required

Locations

Osaka, Japan

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time