Director, Site Quality (Ohio)

​​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 that produces solid oral dosage, Rx, and OTC products. This role ensures that the organization’s internally compounded products meet the 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. They 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.

The Director of Site Quality will be responsible for approving and releasing all compounded products. Other key responsibilities include overseeing site Quality Assurance and Quality Control documentation, managing regulatory inspection activities, and ensuring compliance with industry standards.

Additional duties include managing the Quality department budget, hiring and developing Quality personnel, conducting employee appraisals and competency evaluations, and leading the overall Quality organization.

This position reports to the VP of Quality Non-Sterile and requires working onsite at our New Albany, Ohio facility.

 

You Will:

• 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.
• This role will serve as one of the Designated Person(s) per USP  795 and 797.
• Collaborate closely with the PIC (Pharmacist in Charge) and site GM
• 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 and Quality Control.
• Ensures activities are completed within scheduled timeframes. (i.e. regulatory submissions/reports, CAPAs, investigations, ADRs, complaint closure, and all elements of the Quality System etc.)
• Ensures adequate training (and documentation) of employees to SOPs, and Quality Assurance processes.
• Collaborates in the design and implementation and successful launch of new products. 
• Develop & negotiate Quality Agreements with new and existing direct material suppliers, vendors, and any CDMOs.
• Provide oversight for audits and visits to ensure 3rd party suppliers & vendors meet regulatory requirements.

You Have:

• 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. 
• Experience with solid oral dosage and sterile injectables is a plus
• 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.
• Comfortable working in a fluid environment, and managing fluctuating priorities.
• Demonstrated knowledge and understanding of cGMP requirements and FDA  21CFR Parts 210,211, 11 regulations
• Strong understanding of USP regulations for Compounding Facilities and related requirements.
• Excellent communication skills with the ability to influence and drive both internal and external decisions.

 

Our Benefits (there are more but here are some highlights):

• Competitive salary & equity compensation for full-time roles
• 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
• 401k benefits with employer matching contribution
• Offsite team retreats