Quality Assurance Manager, Post Market Safety

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Requirements:

• Bachelor’s degree in quality assurance, science, medical sciences, pharmacology, or equivalent.
• 5+ years of direct US dietary supplement/Consumer Healthcare Quality experience.
• Knowledge of US FDA guidelines for handling consumer complaints.
• Hands-on experience in adverse events compliance and GMP standards.
• Experience in executing QA GMP compliance for dietary supplements or cosmetics.
• Ability to prioritize and complete multiple projects.
• Strong communication and collaboration skills.
• Professional attitude with strong analytical skills.
• Self-motivated with attention to detail and deadlines.

Responsibilities:

• Management of the Consumer Complaint, Adverse Event Program.
• Ensure consumer contact follow-ups are conducted using appropriate questions.
• Review adverse events to determine if they are potentially serious.
• File serious adverse event reports with FDA for dietary supplements and cosmetics.
• Complete adverse event assessments and investigations.
• Track and trend adverse events monthly and quarterly.
• Monitor metrics and KPIs.
• Work closely with 3rd party medical advisor/PV vendor.
• Support implementation of a consumer complaint, adverse event management database.
• Prepare the adverse event program for audits and inspections.
• Participate as a member of cross-functional teams.
• Perform management tasks including team motivation and workload division.