What are the responsibilities and job description for the Director, Site Quality position at hims & hers?
Hims & Hers Health, Inc. is the leading health and wellness platform on a mission to help the world feel great through better health.
About Hims & Hers
We are revolutionizing telehealth for providers and their patients alike. Making personalized solutions accessible is of paramount importance to us and we focus on continued innovation in this space.
We offer nonprescription products and access to highly personalized prescription solutions for various conditions related to mental health, sexual health, hair care, skincare, heart health, and more.
Our Mission
We are committed to providing high-quality healthcare services to our patients. Our team works tirelessly to ensure that our patients receive the best possible care.
About the Role
Director of Site Quality
The Director of Site Quality is responsible for developing, implementing, evaluating, and maintaining the site's Quality systems, as well as leading the Quality Assurance & Control systems for a 503a registered compounding facility that produces solid oral dosage, Rx, and OTC products.
This role ensures that the organization's internally compounded products meet established standards for quality, integrity, and efficacy.
As a key member of the site leadership team, the Director will partner with Operations leadership to foster a Quality culture that emphasizes Quality by Design and Continuous Improvement.
The Director will direct all aspects of Quality for the company's non-sterile compounding sites and collaborate with other leaders to set policies, ensure adherence to those policies, and comply with relevant state and federal regulations, including those from the boards of pharmacy, USP, and FDA.
Key Responsibilities
- Implement policies and procedures to ensure compliance with relevant statutes and regulations, and meet regulatory reporting requirements for R&D, Compounding, Dispensing, and Fulfillment.
- Develop and lead the Quality Unit team at the site.
- Serve as one of the Designated Person(s) per USP 795 and 797.
- Collaborate closely with the PIC (Pharmacist in Charge) and site GM.
- Provide expertise and guidance in interpreting USP and FDA regulations, agency guidelines, and internal policies to assure compliance.
Requirements
- Bachelor's degree or equivalent in Science or Pharmacy degree preferred.
- 8 years of experience in Quality Assurance with current Good Manufacturing Practices.
- Experience working with 503A, 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.
What We Offer
We offer a comprehensive Total Rewards package that may include an equity grant, competitive salary, 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, and 401k benefits with employer matching contribution.
