Sr Mgr, Post Market Quality
Core
Lead the Global Complaint team to process medical device and pharmaceutical combination product complaints and inquiries, ensuring appropriate handling, evaluation, and regulatory reporting.
Role type
Senior Manager, Post-Market Quality Assurance
Builds
Global complaint processing workflows and regulatory reporting documentation for medical devices, combination products, and biologics.
Domain
Life Sciences / Pharmaceutical / Medical Devices
Deliverable
client delivery
Required skills
Strategic direction setting, global complaint processing oversight, regulatory compliance (GMP, FDA 21 CFR), adverse event identification, formal documentation creation, cross-functional team leadership, project management, stakeholder interface.
Preferred skills
cGMP industry experience, clinical setting experience, FDA Quality Systems knowledge, Medical Device Reporting regulations knowledge, prioritization of multiple projects.
Technologies
Computer systems for word processing and complaint management
Responsibilities
Provide strategic direction and vision for the global complaint processing team; oversee global and US complaint processing methods; assure complaint records meet global requirements; identify potentially reportable events and notify functional groups; author reply letters to customers; lead efforts to resolve complaints; oversee management of project teams for process improvements and new product launches.
Seniority
Senior, hands-on management with strategic oversight