Director of External Lab Quality & Testing Performance - Remote

Overview

The Director of External Lab Quality & Testing Performance will lead and oversee all contract testing laboratories supporting Hims & Hers’ 503A and 503B compounding pharmacy operations, ensuring compliance with regulatory standards and driving continuous improvement.

In Short

• Lead third-party lab oversight and manage quality compliance.
• Ensure labs operate in accordance with all regulatory requirements.
• Drive cross-functional collaboration with internal teams.
• Define and track KPIs for lab performance.
• Manage investigations related to lab performance.
• Support audits and inspections involving external labs.
• Develop and manage quality agreements with contract labs.
• Identify process inefficiencies and lead improvement initiatives.
• Facilitate regular lab performance reviews with stakeholders.

Requirements

• Bachelor’s or advanced degree in Chemistry, Biology, or related field.
• 8–10 years of experience in a cGMP-regulated environment.
• Experience supporting 503A and/or 503B compounding operations.
• Strong understanding of FDA cGMP guidelines.
• Proven success managing external vendors.
• Strong communication and analytical skills.
• Proficiency in investigation and quality systems tools.
• Familiarity with LIMS or lab/sample tracking tools is a plus.
• Experience with sterile product testing preferred.
• Comfort representing the company during regulatory audits.

Benefits

• Flexible and remote work approach.
• Comprehensive benefits package.
• Focus on ethics and wellness.
• Diverse and inclusive work environment.
• Opportunities for professional growth and development.