What are the responsibilities and job description for the Director, Site Quality Professional position at hims & hers?
About Hims & Hers
Hims & Hers Health, Inc. is a leading health and wellness platform revolutionizing telehealth for providers and their patients alike. Our mission is to make personalized solutions accessible, focusing 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. As a public company traded on the NYSE under the ticker symbol 'HIMS', we strive to provide exceptional benefits, culture, and talent-first flexible/remote work approach.
About the Role
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. This role ensures that our 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 emphasizing Quality by Design and Continuous Improvement. They will direct all aspects of Quality for the company's non-sterile compounding sites, collaborating with other leaders to set policies, ensure adherence to those policies, and comply with relevant state and federal regulations.
Main Responsibilities
- Implementing policies and procedures to ensure compliance with relevant statutes and regulations, and meeting regulatory reporting requirements for R&D, Compounding, Dispensing, and Fulfillment.
- Developing and leading the Quality Unit team at the site.
- Serving as one of the Designated Person(s) per USP 795 and 797.
- Closely collaborating with the PIC (Pharmacist in Charge) and site GM.
- Providing expertise and guidance in interpreting USP and FDA regulations, agency guidelines, and internal policies to assure compliance.
- Ensuring quality system performance is measured and routinely reported to executive management.
- Assisting in escorting and providing information to regulatory officials during company audits/inspections.
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.
- Demonstrated experience directly managing teams, including cross-functional people leadership; remote people leadership experience is a plus.
- Experience working in a nimble fast-paced matrix organization.
- Willingness and ability to quickly come up to speed on quality requirements & regulations in new fields.
- Strong understanding of cGMP requirements and FDA 21CFR Parts 210,211, 11 regulations.
- Excellent communication skills with the ability to influence and drive both internal and external decisions.
