Executive Director of R&D Global Quality (Remote)

Overview

Job Summary

We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for leading a global team focused on R&D Quality. This global role includes direct reports in the United States and dotted line reporting in Asia, Europe and North America. The leader of R&D Global Quality will ensure OAPI, OPDC and all affiliates are inspection ready, oversee clinical trial and submission support, lead the R&D audit program, engage with regulatory authorities, and maintain clinical data integrity.

The leader will be responsible for providing a compelling vision for the R&D Global Quality that aligns, supports and complements that of the Global Quality function. The leader shall provide guidance, strategic direction, and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees R&D Global Quality for Otsuka and partners with the business groups and global regions to assure end-to-end Quality, harmonization of processes, and identification and mitigation of Quality risks from development through commercial registration and product distribution.

Responsibilities

• This critical leader will inspire and develop a team of Quality professionals, partner closely with key stakeholders, and assist in the development and delivery of the overall Global Quality (GQ) strategy.
• This position is responsible for ensuring internal and external sites are inspection ready, resources are provided on site and / or remotely during health authority inspections, observational findings are responded to appropriately and within the required timeframe, and resultant CAPAs are implemented and checked for effectiveness to prevent recurrence. A key deliverable of this role will be analysis of findings and holistic assessment of how the organization can address systemic trends to operate more efficiently and effectively.
• This role will take a leadership position in the conduct of clinical facility and system audits at all relevant facilities, investigator sites, and vendors (including contract research organizations) and ensure that audit results are communicated, and appropriate corrective actions are implemented and documented on a timely basis.
• In addition, this role is responsible for establishing standards and implementing procedures to ensure that the business units quality management and compliance program are effective and efficient in identifying, detecting, and correcting non-compliance and mitigating risks, The performance of the Quality Systems and Risks will be reported periodically to Senior Management through the Management Review process to ensure alignment with Company policy and strategy and gain a consensus of risk mitigation approaches.

Key Responsibilities

Qualifications / Required

Knowledge / Experience and Skills :

Qualifications

Competencies

Compensation

Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity : The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws.

Company benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

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

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.

EEO Statement

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 (EEAccommodations@otsuka-us.com).

Fraud / Scam Advisory

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. Otsuka will never ask for financial information or payment during the job application process, and will not ask you to download third-party applications for legitimate opportunities. To ensure legitimacy, only deal directly with Otsuka through its official Career website : https : / / vhr-otsuka.wd1.myworkdayjobs.com / en-US / External. If you suspect a position is fraudulent, contact Otsuka’s call center at 800-363-5670 or the FBI via ic3.gov, or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. do not accept unsolicited assistance from search firms for employment opportunities. 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.

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