Director, Post Market Surveillance

Summary

Join Hims & Hers Health, Inc. as their Director of Post Market Surveillance! Lead the development and management of the company's Post Market Surveillance Quality System, encompassing complaint management, adverse event reporting, and recalls for various product categories. You will oversee a team, ensuring regulatory compliance and driving continuous improvement initiatives. This high-impact role requires strong leadership, analytical, and communication skills, along with extensive experience in product quality management and regulatory frameworks. The ideal candidate will have a deep understanding of 503a and 503b compounding regulations and a proven ability to lead and mentor cross-functional teams. Hims & Hers offers a competitive salary and a comprehensive benefits package, including unlimited PTO, comprehensive health benefits, and an employee stock purchase program.

Requirements

• A bachelor’s degree in a science-related field, pharmacy, quality assurance, or a related discipline (a master’s degree is a plus)
• 8+ years of experience in product quality management, customer complaints, or related fields, with at least 3-5 years in a leadership role
• In-depth knowledge of product complaint handling, root cause analysis, and regulatory requirements (e.g., FDA, 503a and 503b compounding regulations, USP, etc.)
• Strong experience in quality management systems (QMS) and complaint management software
• Proven ability to lead and mentor cross-functional teams, ensuring alignment on customer satisfaction and product quality objectives
• Excellent analytical skills with the ability to identify trends, perform root cause analysis, and implement corrective actions
• Exceptional communication skills, both written and verbal, with the ability to engage stakeholders at all levels of the organization and communicate complex issues clearly and concisely
• A strong understanding of regulatory frameworks related to product safety, adverse event reporting, and product recalls
• Experience with customer-facing interactions and the ability to maintain a positive and professional relationship with customers, even during challenging situations
• Strong project management skills, with the ability to manage multiple tasks and priorities in a fast-paced environment

Responsibilities

• Develop the Hims and Hers Post Market Surveillance Quality System, including complaint management, adverse event reporting, and recalls. Product categories include compounding sterile injectables, tablets, gummies, creams, both Rx and OTC. Focus with 503a and 503b compounding sites
• Lead and manage product complaints quality with the compounding sites, medical affairs, and customer care, ensuring the timely resolution and tracking of customer complaints related to product quality, safety, and performance
• Develop and maintain complaint management processes that comply with regulatory requirements (e.g., FDA, USP, Board of Pharmacy) and align with industry best practices
• Analyze complaint data to identify trends and root causes, and collaborate with product development and quality assurance teams to implement corrective actions
• Ensure customer complaints are thoroughly investigated, documented, and communicated in a timely and transparent manner to customers and relevant stakeholders
• Collaborate with cross-functional teams such as medical affairs, operations, legal, and customer support to resolve product issues efficiently, while protecting both the customer and the brand
• Drive continuous improvement initiatives by leveraging customer feedback and complaint data to identify areas for product or process enhancements
• Ensure regulatory reporting compliance, including the timely submission of adverse event reports, recalls, or corrective actions to appropriate authorities, along with any necessary IT systems required for maintaining compliance
• Develop and manage a high-performing team, providing leadership, coaching, and mentorship to staff handling product complaints
• Create and deliver regular reports and presentations to senior leadership regarding complaint trends, resolutions, root cause analysis, and action plans
• Establish and maintain strong relationships with internal stakeholders (e.g., medical affairs, R&D, quality, operations) and external stakeholders (e.g., customers, regulators, third-party suppliers)
• Monitor and manage departmental budgets, ensuring resources are allocated effectively to support complaint handling and resolution processes

Preferred Qualifications

• Experience in a regulated industry such as pharmaceuticals or compounding facilities
• Experience with ERP or CRM systems and integrating product complaints into broader enterprise systems is a plus
• Knowledge of customer experience management and the role complaints play in customer retention

Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• Employee discounts on hims & hers & Apostrophe online products
• 401k benefits with employer matching contribution
• Offsite team retreats