Senior Associate, GPQ Investigator

Otsuka Pharmaceutical Co., Ltd.•Princeton, NJ

12d•$89,622 - $128,800

About The Position

The Senior Associate PQC Investigator, Global Product Quality – Global GMP Processes and Devices supports Product Quality Complaint activities for commercial medical devices, combination products, and medicinal products. The role coordinates complaint intake, conducts investigations, documents findings, and assists with complaint resolution while partnering with cross-functional stakeholders to ensure compliance with applicable regulations, GMP requirements, and internal procedures. The position also supports complaint trend monitoring, risk-management metrics, quality reporting, complaint reconciliation, and potential recall or reporting activities. It helps maintain accurate, complete complaint records and supports internal GMP audits and external regulatory inspections.

Requirements

Strong knowledge of regulatory requirements, specifically 21 CFR Parts 210, 211, 820, and 803 as they apply to complaint handling, investigations, and documentation.
Ability to manage multiple investigations simultaneously.
Analytical, problem-solving, and troubleshooting skills, with a process-optimization and improvement mindset.
Proficiency in MS Office software.
Strong interpersonal, communication, and writing skills, and the ability to multitask.
Ability to work in a team environment.

Nice To Haves

Experience with electronic quality systems such as the TrackWise complaints module or Veeva Vault.
Bachelor’s degree.
Three or more years of Quality Assurance experience, including product quality complaint investigations in the pharmaceutical and/or medical device industry.

Responsibilities

Support intake, documentation, coordination, investigation, resolution, replacement or reimbursement, and closeout of Product Quality Complaints in a timely manner and in compliance with Otsuka and regulatory requirements.
Support the PQC distribution mailbox and complaint mailbox.
Assist with complaint sample retrieval.
Follow up with complainants, including patients, sales representatives, hospitals, pharmacies, and physicians, to obtain relevant information; escalate complex or sensitive interactions when appropriate.
Summarize complaint files to ensure appropriate documentation, coordination, investigation, and resolution in compliance with regulatory and Otsuka requirements.
Assist with critical complaints, including management notification under established procedures and follow-up with reporters as required.
Assist in reviewing complaint documentation for proper triage and provide management feedback about discrepancies.
Monitor complaints for product trends, notify management of events requiring immediate action, and support trend investigations as applicable.
Support monthly and quarterly PQC metrics for all products.
Coordinate metrics for QRT meetings and compile meeting notes.
Manage and update product FAQ documents based on complaint type.
Support compilation and maintenance of data for risk-management metrics for drug/device combination products and medical devices.
Evaluate complaints for evidence of device malfunction, performance deficiencies, or use-related issues and ensure timely escalation for further review and investigation.
Support potential recall and reporting action activities.
Support reconciliation processes with teams such as the call center, Pharmacovigilance, and medical information to meet procedural requirements and timelines.
Ensure complaint records are accurate, complete, and maintained in accordance with procedures, record-retention requirements, and data-integrity principles.
Support, manage, and complete assigned projects in accordance with Otsuka requirements.
Support internal GMP audits and external regulatory inspections.
Complete all assigned training in a timely manner.