Manager, Quality Assurance

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve. 

Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.

About the Role:

The Quality Manager is responsible for overseeing the Quality Assurance (QA) teams to ensure compliance with FDA regulations, state regulations,cGMP standards, and USP requirements within a 503B outsourcing facility. This role focuses on managing quality systems, ensuring product quality, quality team member development, and driving continuous improvement initiatives across the organization.

You Will:

• Supervise and provide guidance to the Quality Control Specialist and Quality Assurance Specialist, ensuring alignment with organizational and regulatory quality goals.

• Build and maintain a culture of quality excellence and compliance across the facility. 

• Set performance objectives for QC and QA teams and provide regular feedback and performance evaluations. 

• Identify opportunities for improvement within the Quality Management System and implement program changes for continuous quality improvement.

• Manage the implementation and maintenance of the Quality Management System (QMS) to ensure compliance with 21 CFR Parts 210/211, 503b guidance, USP <797>, <800>, and ISO 14644. 

• Oversee the review and approval of batch records, deviations, investigations, CAPAs, and change controls. 

• Ensure the execution of environmental monitoring programs and the maintenance of ISO-classified cleanroom environments. 

• Manage and monitor compliance with equipment qualification (IQ/OQ/PQ), process validation, and cleaning validation.

• Ensure all quality activities meet FDA and other regulatory requirements for sterile pharmaceutical production.

• Oversight for customer complaint handling, ensuring it aligns with 21 CFR Part 211.198. Ensure the process includes steps for complaint intake, investigation, resolution, documentation, and trending. 

• Prepare for and participate in regulatory inspections and customer audits.

• Collaborate with the Director of Quality to address any findings or deficiencies, ensuring timely resolution.

• Analyze quality metrics and trends to identify areas for improvement.

• Implement corrective and preventive actions (CAPAs) to address quality issues and enhance processes. 

• Drive cross-departmental collaboration to improve operational efficiency and product quality.

• Ensure all personnel are adequately trained on SOPs, regulatory requirements, and quality systems. 

• Develop and deliver training programs to foster a culture of compliance and continuous improvement.

• Ensure quality documentation is accurate, complete, and audit-ready at all times.

• Generate and present quality reports, metrics, and performance summaries to senior management.

• Other Projects assigned based on business needs
  

You Have:

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy, or a related field. Advanced degree (e.g., Master’s or MBA) preferred.

• Minimum 5+ years of experience in quality roles within a 503B outsourcing facility or a pharmaceutical manufacturing environment. 

• At least 3 years of experience in a leadership or management role.

• Candidate must be willing to receive a pharmacy trainee license within the first 6 months of employment, and further continue to a pharmacy technician within 3 years.

• In-depth knowledge of FDA 21 CFR Parts 210/211, USP <797>, USP <800>, and cGMP standards. 

• Experience with qualit