Product Complaints Quality Manager (Contract)
About The Position
The Product Complaint Manager supports Vertex’s Product Complaint Quality System and quality activities across the Small Molecule, Biologics, and Device CMC Compliance team. The role partners with 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. This is a 12-month contract with the chance to extend. The schedule is Monday through Friday, with three days onsite. The role is offered through a third-party agency partner, and the position is eligible for overtime pay in accordance with federal and state requirements.
Requirements
- A master’s degree and 3–4 years of relevant work experience, or a bachelor’s degree in a scientific or allied health field and 8 or more years of relevant work experience, or a relevant comparable background.
- Experience in a Quality Assurance role supporting complaint management and root cause investigations and CAPA development in at least one of these areas: devices, biologics, or small molecules.
Nice To Haves
- 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 the product lifecycle.
- Knowledge and application of GMP/GDP regulations and their application to product complaints and medical devices.
- Strong collaboration skills and ability to thrive in a fast-paced environment.
- Critical, analytical, and strategic thinking skills.
- Investigation, root cause, and CAPA experience.
Responsibilities
- Support product complaint process activities, including reconciliation, training, complaint sample management, triage, trending, and SOP management.
- Process incoming clinical and commercial product complaints, including intake, initial evaluation, and triage.
- Conduct product complaint investigations and author investigation reports; coordinate with contract manufacturing organizations as needed for external investigations.
- Perform quality reviews of complaint investigations owned or authored by other team members.
- Escalate critical issues to senior management.
- Assist with product complaint trending, including computing metrics and authoring quarterly reports.
- Train cross-functional teams on the product complaint process.
- Support complaint-related quality activities, including reviewing deviations and SOPs and representing the team at cross-functional meetings as needed.
- Evaluate new regulatory intelligence related to the product complaint system and update processes and procedures as necessary.
- Identify areas for improvement and participate in process improvement initiatives.
Benefits
- Eligible for overtime pay in accordance with federal and state requirements.
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What This Job Offers
Career Level
Manager
