Position Overview: The Senior Director of Global Quality Management – GCP and GVP will be responsible for overseeing the development, implementation, and maintenance of quality management systems and practices related to GCP and GVP across the organization. This role will ensure compliance with regulatory requirements, industry standards, and internal policies to guarantee the highest quality and integrity of clinical trials and data.

Job Responsibilities:

Provide quality oversight to assure that clinical and or safety activities are conducted in compliance with applicable regulations and Otsuka policies to ensure data integrity and to safeguard the rights, safety, and well-being of subjects, patients, and consumers

Provide overall coordination and oversight of the functioning of the GCP and GVP Quality Management System

Ensure procedures are in place that adequately define the expectations for work that supports, or directly affects, product registration and/or the integrity of data that supports product quality and patient or consumer safety and the studies undertaken to demonstrate safety and efficacy

Oversight and continual improvement of cross-line quality systems (e.g. issue management and escalation, CAPA management) to ensure the QMS is effective within the GQM pillar and in alignment with other pillars

Establishing, monitoring, and reporting on Key Performance Indicators (KPI) related to Quality across lines, providing visibility into the state of control as it relates to Quality Oversight of the functioning of the QMS governance model within the GQM pillar. Be responsible for collation and communication to management within  the US and Japan pertaining to the risks associated with clinical activity undertaken by Otsuka worldwide

Develop and execute the global quality management strategy for GCP and GVP to support the company’s clinical development objectives. Provide strategic direction and leadership to ensure quality standards are integrated into clinical operations and processes.

Understand external quality trends and innovation within the space to support the evolution of Otsuka’s Quality processes, technology and people

Collaborate with cross-functional teams, including Clinical Operations, Regulatory Affairs, & Pharmacovigilance, to ensure alignment on quality-related issues. Serve as the primary point of contact for GCP quality matters and provide guidance to internal and external stakeholders.

Design, implement, and maintain a robust GCP quality management system, including policies, procedures, and quality metrics. Lead continuous improvement initiatives to enhance the quality management system.

Work with functional partners/ROS to assure the oversight and quality performance of Contract Research Organizations (CROs) and other external partners. Ensure proper qualification and oversight of third-party service providers.

Coordinate and Manage health authority inspections of GCP and GVP activities in collaboration with respective functions

Provide oversight to Risk-Based Audit for Clinical Sites, Vendors, GXP Systems (GCP and GVP Focus)

Collaborate with clinical functions on Quality Oversight for Clinical trials management; risk assessment & operational data oversight in clinical program areas

Contribute and be a strong enabler with quality oversight and guidance for corporate projects R&D innovation for clinical teams

Provide Clinical Trial data integrity program enabler and oversight

When necessary deputise for the Pillar head of GQM

In collaboration with Pillar head provide guidance and direction to the Otsuka organization with respect to Good Clinical and Pharmacovigilance practices.

Preferred Qualifications:

Advance degree such as Pharm D., MD., or PhD. in the sciences

18+ years of experience in the pharmaceutical/ biotechnology industry

Minimum 10 years of experience in GxP Quality role, with 5+ years in management

Proven ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs

Experience with multiple aspects of the product development (R&D, nonclinical and clinical)

Strong knowledge of US and other major global (ICH, EU, Asian) regulatory compliance requirements

Experienced in handling FDA and other Regulatory Health Authority interactions including but not limited to inspections

Ability to manage and prioritize multiple tasks

Excellent communication skills, both written and oral. Ability to effectively present information to all levels of the organization worldwide and across affiliates

Must be able to effectively collaborate with peers and comfortable working in a matrixed team

Must be solutions oriented and pragmatic (with analytical thinking and problem-solving skills)

Excellent project management and organization skills is a must

Knowledge and experience of multiple classes of products used in Otsuka clinical studies including small and large molecules, Devices and combination products and Software as Medical devices, with a view to providing guidance and advice on the conduct of studies and safety evaluations for all classes

Data literacy

Preferred background of biologics, controlled substance and/or early phase R&D

Lean/six sigma/kaizen or other similar experience

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. 

Otsuka is an equal opportunity employer.  All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.   

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability.  You can request reasonable accommodations by contacting Accommodation Request. 

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