QA Manager, Consumer Complaint & Adverse Events

Summary

Join Nutrafol as the Quality Assurance Manager and lead the Consumer Complaint/Adverse Event Management Program. You will leverage your expertise in dietary supplements and cosmetics to ensure compliance with FDA guidelines. This role involves managing adverse events, conducting investigations, and collaborating with internal and external stakeholders. You will report directly to the Director, QA, and contribute to the growth and protection of the business. The position requires a Bachelor's degree, 5+ years of relevant experience, and strong communication and analytical skills. Nutrafol offers a competitive salary, comprehensive benefits, and a fully remote work environment.

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

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

Benefits

• Fully remote work experience
• Comprehensive medical, dental, and vision package, including FSA program
• 401K with 50% match
• Quarterly Bonus Program
• Flexible PTO
• Two company-wide wellness breaks every day
• Free lunch on us every Tuesday and Thursday via Seamless/Grubhub
• Monthly wellness stipend
• Monthly internet stipend
• Monthly cell phone stipend
• Annual learning & development stipend
• Wellness Program, including virtual Wellness Sessions & No-Meeting Wednesdays
• Free meditation app membership (Headspace)
• Free Nutrafol subscription
• Pet insurance and benefit programs