Director, Quality

Hims & Hers Health, Inc. (better known as 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 revolutionizing telehealth for providers and their patients alike. Making personalized solutions accessible is of paramount importance to Hims & Hers and we are focused on continued innovation in this space. Hims & Hers offers nonprescription products and access to highly personalized prescription solutions for a variety of conditions related to mental health, sexual health, hair care, skincare, heart health, and more.

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 and forhers.com, or visit our investor site. 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 Director of Quality Assurance will be responsible for developing, implementing, evaluating, and maintaining the site Quality systems and leadership of the site’s Quality Assurance & Control systems.  They will report to the SVP of Pharmacy Safety, Quality, and Compliance.  They will ensure the organization’s internally compounded products meet the quality, integrity, and efficacy standards set by the organization.  They are a member of the site leadership who, in partnership with Operations leadership, will champion the creation of a Quality culture that embodies Quality by Design and Continuous Improvement expectations.  Directs all Quality aspects of the company’s compounding sites.  Interacted with other leadership team members to help set policies and guide adherence to them, as well as any applicable state and federal standards from the boards of pharmacy, USP, and FDA.  Responsible for the decision on approval and release of all compounded products. Organizational responsibilities include site Quality Assurance, Quality Control documentation, and regulatory inspection activities.  Additional responsibilities include managing the Quality department budget, hiring and developing Quality personnel, performing employee appraisals/competency evaluations, and managing the Quality organization.

You Will:

• Implements policies and procedures to ensure that these comply with the appropriate statutes and regulations and ensure that regulatory reporting requirements are met. 
• Provides expertise and guidance in interpreting USP and FDA regulations, agency guidelines, and internal policies to assure compliance. 
• Ensure quality system performance is measured and routinely reported to the executive management. 
• Assist in escorting and providing information to regulatory officials during company audits/inspections.
• Performs a variety of managerial tasks and duties to ensure the appropriate day-to-day operations of Quality Assurance, Quality Control, and Regulatory Affairs.
• Ensures activities are completed within scheduled timeframes. (i.e. regulatory submissions/reports, CAPAs, investigations, ADRs, complaint closure, etc.)
• Ensures adequate training (and documentation) of employees to SOPs, and Quality Assurance processes.
• Collaborates in the design and implementation of new products. 
• Ensures that products meet design specifications
• Works closely with labs to ensure methods and analysis are appropriate for product label claims
• Assist in the development of internal QC laboratory methods
• Develop & negotiate Quality Agreements with new and existing direct material suppliers & vendors
• Provide oversight for audits and visits to ensure 3rd party suppliers & vendors meet regulatory requirements
• Manage relationships with 3rd party Quality vendors

You Have:

• Bachelor’s degree or equivalent in Science or Pharmacy degree preferred. 
• 8+ years experience in Quality Assurance with current Good Manufacturing Practices.
• Experience working with 503B Outsourcing facilities or pharmaceutical manufacturing is required. 
• Must have experience with implementing new Quality Assurance and/or Control systems & processes in a high-growth environment. 
• Demonstrated experience directly managing teams, including cross-functional people leadership; remote people leadership experience is a plus.
• Experience working in a matrix organization
• Willingness and ability to quickly come up to speed on quality requirements & regulations in new fields.
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