Associate Director, Quality Systems

The Associate Director Quality System is responsible for monitoring the effectiveness of the GxP Quality Management Systems regarding CAPA, Deviations, Investigations, and Change Management for OPDC/OAPI.

S/he is the Global process owner for the CAPA and Deviation. S/he leads the development and continuous improvement of these processes across GxPs. Provide guidance and support eQCMS (TrackWise or similar system) enhancements in collaboration with Global Quality Systems. Provide guidance and perform a risk assessment for global CAPA and Deviation.

Provides guidance to quality record owners to ensure documentation is accurate, complete, timely, and compliance to meet Health Authority and Otsuka processes.

Responsible to collect Quality System GXPs metrics and KPIs for Management Review.

Leads the local Quality Review Team to provide guidance and training to record owners thereby ensuring the content of Quality System records is accurate and complete, and corrective actions are implemented and closed within prescribed timelines.

Job Responsibilities

• Lead continuous improvement of Quality Management Systems, such as CAPA, Deviation, Investigation, and Change Management, and direct the efforts to develop, implement and maintain compliant and effective Quality Systems.
• Generate Monthly and Quarterly Metrics for periodic Quality Management reviews.
• Identify and support quality management system improvement initiatives by working closely with Global Quality department and other key stakeholders.
• Support the Trackwise Global Quality System for Deviation, Investigation, CAPA, Change Management enhancements and associated activities. Review and approve quality management system records as required.
• Monitors Quality Management Systems for trends and notify management of events requiring and immediate action.
• Identify compliance gaps and lead focused teams to resolve compliance issues.
• Lead department projects of varying complexity.
• Lead the development, monitoring and maintenance of GMP/QMSR standards and processes to ensure compliance with local and global regulations.
• Maintain current knowledge of GMP Compliance program and of applicable company standard operating procedures for areas of responsibility.
• Provide guidance on interpretation and application of specified QA/GMP compliance regulations, i.e.: 21 CFR Part 210/211, 600, 820, Drug/Device Combination products.
• As required participates in compliance inspections and audits.

Qualifications Required:

• 10+ years of Quality Assurance experience in the Pharmaceutical (Drug/Biologics), Drug Device Combination Product and/or Medical Device industry.
• Including 2 to 3 years of Manufacturing and Packaging QA/QC experience
• Experience in Quality Systems and determining reportability to the FDA and other regulatory agencies.
• Strong knowledge of regulatory requirements (i.e. 21 CFR Parts 210, 211, 600, 820, ISO 13485, Drug Biologic Combination product)
• Excellent analytical, problem solving, and troubleshooting skills.
• Proficient in MS Office software, Trackwise, Document Management System
• Strong interpersonal and communication skills
• Ability to work in a team environment.
• Ability to multi-task
• Travel (approximately 10%)

Qualifications Preferred:

• Knowledge in using statistical techniques to identify trends and root causes from quality data sources (e.g., deviations, CAPAs, audit findings, complaints, investigations).
• Knowledge of applying AI/ML models to predict quality issues, product performance, or process deviations, enabling proactive risk mitigation across Quality Management System processes.
• Integrating advanced analytics and digital tools into Quality Management System to support continuous improvement and inspection readiness.

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.

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 t