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Product Complaint Manager

Katalyst Healthcares & Life Sciences

Boston, MA

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JOB DETAILS
SKILLS
Analysis Skills, Best Practices, CMOS, Call Centers, Communication Skills, Contract Manufacturing, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, GMP (Good Manufacturing Practices), GxP, Industry Standards, Investigative Reports, Medical Equipment, Medical Products, Medical Records, Metrics, PC (Personal Computer) Systems, Patient Safety, Process Improvement, Product Lifecycle, Product Support, Project/Program Management, Quality Assurance, Reconciliation, Regulations, Reporting Skills, Root Cause Analysis, Small Molecules, Specimens/Samples, Standard Operating Procedures (SOP), Supply Chain, Systems Maintenance, Technical Presentation, Technical Writing, Time Management, Training/Teaching, Writing Skills
LOCATION
Boston, MA
POSTED
30+ days ago
Job Description:
  • The Product Complaint Manager is responsible for supporting the Product Complaint Quality System at our 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 Centres.
  • Must have excellent communication.
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.
Requirements:
  • 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.

About the Company

K

Katalyst Healthcares & Life Sciences

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