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:

• Bachelor's Degree and 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 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.

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 https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.

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: https://www.ic3.gov,  or your local authorities.

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and 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.