Job Description

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; . Disclaimer: 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 . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters. To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website . Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., a nd Otsuka Precision Health, Inc. (Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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