Product Complaints Quality Manager

The Product Complaint Manager is responsible for supporting the Product Complaint Quality System s 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.

• 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 andtriage
• 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 orallied health field and 8+ years of relevant work experience, or relevant comparable background.
• Must have 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

Contract Length: 12 months with the chance to extend

$50/hr.

- $55/hr.

Monday - Friday;
Hybrid - 3 days onsite

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.

The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements

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