Duration: 12 months to start

Job Description:
The Product Complaint Manager is responsible for supporting the Product Complaint Quality Systems for the client. This role will support quality activities associated within the Small Molecule, Biologics, Device CMC Compliance team and will partner with various internal and external cross-functional teams including Global Patient Safety, Supply Chain/Trade and Distribution, Medical Information, Guidance and Patient Support, Quality Assurance, Contract Manufacturing Organizations and external Call Centers.

Key Responsibilities:

• Support activities associated with the product complaint process, including reconciliation, training, complaint sample management, triage, trending, SOP management, etc.
• Process incoming clinical and commercial product complaints, including intake, initial evaluation and triage
• Conduct product complaint investigations and author investigation reports. Coordinate with CMOs as needed for external investigations.
• Perform quality review of complaint investigations owned/authored by other members of the team.
• Escalate critical issues to senior management.
• Assist with the PC trending process, including metrics computation and quarterly report authoring.
• Provide training to cross functional teams on the product complaint process.
• Support quality activities associated with product complaints, including deviation and SOP review, representing the team as necessary at cross functional meetings, etc.
• Evaluate new regulatory intelligence related to the PC system and update processes/procedures as necessary.
• Identify areas of improvement and participate in process improvement initiatives.

• Master’s degree and 3-4 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field and 8+ years of relevant work experience, or relevant comparable background.
• Must have extensive experience in a Quality Assurance role supporting complaint management and root cause investigations / CAPA development in at least one of the following areas: device, biologics or small molecule.

• Understanding of industry standards and best practices
• Proven ability to manage projects of significant scope and complexity, while meeting deliverable timelines.
• Excellent technical writing, presentation, and communication skills.
• Broad GxP Knowledge and understanding across lifecycle of the product
• Knowledge and application of GMP/GDP regulations and application to product complaints and medical devices
• Strong collaboration skills with the ability to thrive in a fast-paced environment
• Critical, Analytical and Strategic thinking skills
• Investigation, Root Cause and CAPA experience