Senior Associate, GPQ Investigator

The Senior Associate PQC Investigator, Global Product Quality - Global GMP Processes and Devices supports Product Quality Complaint activities by coordinating complaint intake, conducting investigations, documenting findings, and assisting with complaint resolution for commercial medical devices, combination products, and medicinal products. Partners with cross-functional stakeholders to ensure complaint processes are executed in compliance with applicable regulations, GMP requirements, and internal procedure.

Key Job Responsibilities

• Support the intake, documentation, coordination, investigation, resolution, {replacement/reimbursement} and closeout) of Product Quality Complaints in timely manner that complies with Otsuka requirements and Regulatory requirements (21CFR Parts 210, 211, 820, 803).
• Support the PQC distribution mailbox as well as complaint mailbox
• Assist with Complaint Sample retrieval
• Follow-up with Complainant (Patient, Sales Reps, Hospitals, Pharmacies and Physicians etc.) to obtain applicable information pertaining to reported events. Escalate complex or sensitive interactions to senior team members when appropriate
• Summarize complaint files to ensure proper documentation, coordination, investigation, resolution, which adheres compliance to regulatory requirements as well as Otsuka requirements.
• Assist with Critical complaints including notification to management in accordance with established procedures, follow-up with the reporter as required.
• Assist in the review of compliant documentation to ensure proper triage and provide feedback to management if any discrepancy is found.
• Assist in monitoring complaints for product trends and notify management of events requiring immediate Action. As applicable, support with conducting trend investigation.
• Support monthly and quarterly PQC metrics for all products.
• Engage and coordinate metrics for QRT meetings and compile meeting notes.
• Manage and update product FAQ documents based upon complaint type.
• Support with compiling and maintaining data used for Risk Management metrics for Drug/Device combination product and Medical Device product.
• Support with the evaluation of complaints for evidence of device malfunction, performance deficiencies, or use-related issues, and ensure timely escalation for further review and investigation as required
• Support any potential recall and/or reporting action activities.
• Support reconciliation processes in coordination with other teams (call center, Pharmacovigilance, and medical information etc.) to ensure it meets procedure requirement and timely completion.
• Ensure complaint records are accurate, complete, and maintained in accordance with applicable procedures, record retention requirements, and data integrity principles.
• Support, manage and complete assigned projects in accordance with Otsuka requirements.
• Support Internal GMP audit and External Regulatory inspections.
• Complete all assigned training in a timely manner

Knowledge/ Experience and Skills:

Required:

• Strong knowledge of regulatory requirements (21 CFR Parts 210, 211, 820, 803) specifically those applicable to complaint handling, investigations, and documentation

• Abilify to manage multiple investigations simultaneously

• Analytical, problem solving, and troubleshooting skills with process optimization and improvement mindset

• Preferred experience with electronic quality systems (TrackWise complaints module, Veeva Vault, etc.)

• Proficient in MS Office software

• Strong interpersonal and communication skills, writing skills and ability to multitask.

• Ability to work in a team environment.

Educational Qualifications

• Preferred Bachelor's Degree with 3+ years of Quality Assurance experience including product quality complaint investigations in the pharmaceutical and/or medical device industry

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.

Minimum $89,622.00 - Maximum $128,800.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

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.

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