What are the responsibilities and job description for the Quality Assurance Leadership Role position at hims & hers?
Join Our Team
Hims & Hers Health, Inc. is seeking an experienced Director of Site Quality to lead our non-sterile compounding site's Quality Assurance and Quality Control systems. As a key member of our site leadership team, you will be responsible for ensuring that our internally compounded products meet the highest standards for quality, integrity, and efficacy.
You will develop, implement, evaluate, and maintain the site's Quality systems, while also leading the Quality Assurance & Control systems for our 503a registered compounding facility. Your expertise will be essential in fostering a Quality culture that emphasizes Quality by Design and Continuous Improvement.
About the Position
This role requires strong leadership and organizational skills, with the ability to manage cross-functional teams and collaborate with other leaders to set policies and ensure compliance with relevant regulations. You will be responsible for implementing policies and procedures to ensure compliance with relevant statutes and regulations, and meeting regulatory reporting requirements for R&D, Compounding, Dispensing, and Fulfillment.
Main Responsibilities
- 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.
