Senior Director, Global Quality Management- GCP

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Job description

Position Summary:
The Senior Director for Global Quality Management - GCP will provide guidance, strategic direction, and leadership to the Global Quality (GQ) unit with responsibilities for Global Clinical Quality (GCQ), CSV and GVP. · In this role, the incumbent oversees GCQ operations for the company 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 of the product, distribution and volunteer/patient use. 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. 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 Job Responsibilities:

• Develops, implements, and maintains policies, systems and procedures describing internal processes for management of quality and compliance with applicable regulations and guidelines that ensure sustained GCP/QSR compliance

• Leads and develops systems for Clinical vendor management and vendor oversight.

• Develop, implement, execute the GCP, GVP and CSV audit strategy and plan using a risk-based approach.

• Plan and manage the conduct of GCP, GVP, CSV internal audits and external audits (vendors, clinical sites, partner, etc.) to assure that departments are meeting regulatory requirements and are in compliance with Global and Local procedures.

• Interface with relevant departments, including regulatory, clinical outsourcing, clinical sub teams and others, as applicable, to provide Good Clinical Practice and QA compliance expertise.

• Lead GCP and GVP Regulatory health authority inspections activities and the development of corrective actions for findings from such inspections

• Establish and maintain a system to ensure R&D Management Reviews are conducted per QSR and Company requirements.

• Establish and maintain systems to ensure product quality complaints arising from OPDC Clinical trials are received, reviewed, evaluated, trended, and documented in a uniform and timely manner.

• Provides leadership in the coordination and management of any field corrections, or clinical stock recoveries of product from the clinical study sites and IMP distribution network.

• Develop and manage the departmental budgets

• Develop and mentor direct reports for leadership opportunities

• Identify continuous improvement opportunities, new technologies, and innovations and implement processes and system that increase efficiency and compliance.

Required:

• Bachelor's degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment

• Strong knowledge of current global Good Clinical Practice (GCP) for designing, recording and reporting trials that involve the participation of human subjects. Managing compliance with this standard to provide assurance that the rights, safety and wellbeing of trial subjects are protected, and that clinical-trial data are credible. Current and in-depth knowledge of audit techniques and government regulatory inspection procedures

• Working knowledge of current Good Manufacturing Practice (cGMP) regulations

• Strong project management, leadership, problem solving, and organization skills

• Excellent interpersonal and communication skills

• High level of emotional intelligence

• Proficiency in Microsoft Office applications

• Travel (approximately 30%)

Preferred:

• MBA or M.S. + 10 years of relevant experience

• Previous experience of working in the global pharmaceutical and medical device industry

• Experience working with external service providers

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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 receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

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