Remote Product Quality & Complaints Manager

Sumitomo Pharma America, Inc; Town of Marlborough (NY); Remote; USD 112,000 - 140,000; Full time

Benefits offered by this job

401(k) plan

Medical insurance

Dental insurance

Vision insurance

Life insurance

Disability insurance

Paid time off

Holiday leave

Job summary

Sumitomo Pharma America, Inc. is seeking a Quality Assurance professional focused on pharmacovigilance and product complaints.

The role reports to the Senior Director, PV Quality Assurance within the Quality department and collaborates with PV, Manufacturing, and external partners to ensure patient safety and regulatory compliance. The ideal candidate will manage intake, investigation, documentation, and closure of product complaints for commercial and clinical products, maintaining inspection

Qualifications

• Bachelor’s degree in a related field required.
• Minimum 4 years of biotech/pharma experience in complaints, investigations, quality systems.
• Working knowledge of cGMP requirements and quality management systems.
• Experience with product complaints and regulatory compliance.
• Travel up to domestic and international; primarily remote with on-site meetings.

Responsibilities

• Manage intake, assessment, documentation, investigation, and closure of product complaints for commercial and clinical products in accordance with applicable regulations and company procedures.
• Receive, evaluate, and process product complaints, including identification and forwarding of potential adverse event, lack-of-effect, and product quality reports to appropriate functions.
• Conduct and coordinate complaint investigations with internal and external stakeholders to obtain information necessary to support complaint evaluations and product quality assessments.
• Ensure complaint records are complete, accurate, well-written, fact-based, and maintained in a state of inspection readiness.
• Manage follow-up activities with consumers, healthcare professionals, pharmacies, distributors, and other external contacts as necessary to obtain complaint information and supporting documentation.

Skills

FDA GMP knowledge

Pharmacovigilance

Investigations

Root cause analysis

eQMS experience

Communication skills

Prioritization

Documentation quality

Education

Bachelor's degree in a related field

Tools

eQMS

Complaint databases

Job description

Sumitomo Pharma America, Inc. is seeking a Quality Assurance professional focused on pharmacovigilance and product complaints.

The role reports to the Senior Director, PV Quality Assurance within the Quality department and collaborates with PV, Manufacturing, and external partners to ensure patient safety and regulatory compliance. The ideal candidate will manage intake, investigation, documentation, and closure of product complaints for commercial and clinical products, maintaining inspection