Senior Associate, GPQ Investigator

Otsuka Pharmaceutical Companies (U.S.); Princeton (NJ); Sur place; USD 90 000 - 129 000; Plein temps

Avantages offerts par ce poste

Medical coverage

Dental coverage

401(k) match

Résumé du poste

Otsuka Pharmaceutical Companies (U.S.) seeks a Senior Associate PQC Investigator, Global Product Quality – Global GMP Processes and Devices. The role coordinates complaint intake, investigations, and documentation for medical devices, combination products, and medicinal products.

You will partner with cross-functional teams to ensure compliant processes, review data, and support timely escalation, trend monitoring, and PQC metrics.

Qualifications

• Regulatory requirements knowledge (21 CFR Parts 210, 211, 820, 803).
• Experience with product quality complaints investigations preferred.
• Knowledge of electronic quality systems helpful.

Responsabilités

• Coordinate intake, investigation, resolution, and closeout of Product Quality Complaints in compliance with Otsuka requirements and regulations.
• Support PQC mailbox and complaint mailbox management.
• Assist with complaint sample retrieval and data retrieval for investigations.
• Follow up with reporters to obtain necessary information and escalate complex cases.
• Summarize files to ensure proper documentation and regulatory compliance.
• Assist in monitoring complaints for trends and notify management of urgent issues.
• Support PQC metrics and prepare for QRT meetings.

Connaissances

Regulatory knowledge

Analytical thinking

Communication skills

Team collaboration

Multitasking

Formation

Bachelor’s Degree in QA/Science

Outils

TrackWise

Veeva Vault

MS Office

Description du poste

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.

Salary

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.

Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.

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 be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].