QA Manager (regulatory focused)

About You

As Quality Assurance Manager for Nutrafol, you will be responsible for leading the Consumer Complaint/Adverse Event Management Program. In support of the growing platform of products and formats spanning the business portfolios, you will bring deep expertise and experience in the dietary supplement and cosmetic categories and have strong knowledge and experience in ensuring adverse event compliance in adherence to FDA guidelines and regulations. This expertise will enable Nutrafol to continue to grow as a competitive and agile business in the categories that it operates within.

You will be responsible for executing end-to-end adverse event management support that will help grow and protect the business. This role reports directly into the Director, QA. 

Responsibilities:

• Management of the Consumer Complaint, Adverse Event Program
• Ensure consumer contact follow-ups are conducted using appropriate questions as required
• Review adverse events to determine if they are potentially serious
• File serious adverse event reports with FDA as required for dietary supplements and cosmetic products
• Complete adverse event assessments and investigations
• Track and trend adverse events on a monthly and quarterly basis
• Monitor metrics and KPIs (key performance indicators)
• Work closely with 3rd party medical advisor/PV vendor as required
• Support the implementation of a consumer complaint, adverse event management database.
• Gather in-depth adverse event information to address specific inquiries from colleagues and collaborators.
• Ensure the consumer complaint, adverse event program is prepared for internal and 3rd party audits as well as regulatory inspections.
• Participate as an effective member of cross-functional teams.
• Demonstrate ability to lead in a collaborative environment with a positive leadership style and a hands-on approach that emphasizes teamwork, collaboration, motivation, and consensus and team building.
• Perform management tasks for the team, which include conducting reviews, maintaining team motivation and dividing the workload among team members.
• Assists with ad hoc projects as required. 

Requirements:

• Bachelor’s degree in quality assurance, science, medical sciences, pharmacology etc.; or an equivalent combination of education and experience sufficient to successfully perform the key accountabilities of the job required.
• 5+ years of direct US dietary supplement/Consumer Healthcare Quality experience within a wellness/supplement brand. 
• Well versed and knowledgeable regarding US FDA guidelines and regulations for handling consumer complaints, especially for dietary supplements and cosmetic products. 
• Hands-on experience in adverse events compliance and GMP standards.
• Experience executing QA GMP compliance for a broad portfolio of dietary supplements, cosmetics or related products.
• Effectively prioritized and completed multiple projects in an agile and fast-paced environment.
• Proven ability to communicate and collaborate effectively with a variety of audiences, both internal and external.
• Consistently demonstrated a professional, positive, and approachable attitude.
• Strong analytical, organizational and critical thinking skills.
• Demonstrates team player mentality with ability to work independently.
• Self-motivated with critical attention to detail, deadlines, and reporting.
• Excellent English written and verbal communication skills.