Director of Quality en Strive Pharmacy
Strive Pharmacy · Gilbert, Estados Unidos De América · Hybrid
- Senior
- Oficina en Gilbert
Company Overview
Before we opened Strive Pharmacy we were unsatisfied with the current state of the pharmaceutical industry. Most of the current pharmaceuticals only offer a one size fits all approach and often come with unwanted and potentially dangerous side effects. We found that through compounding we can offer a much more personalized solution to medicine.
Through this we have been able to help patients get the results they are seeking for their personal needs. After years of working for corporate chains we took the risk and opened Strive Pharmacy. We are dedicated to providing a better experience for each customer and clinic that we work with. Come see the Strive difference.
Our Mission
We’re flipping the script with personal medicine. We strive to interrupt an industry that has been closed to personalized care, accessibility, and nuance for too long. We strive to shift a reactive view of self-care and ignite a proactive baseline-shifting approach to health for all. ‘The human element’ is our crux and catalyst, driving all that we do, whether we’re interacting with patients, providers, or practices. We’re here to partner with those ready for a change. More than a compounding pharmacy, we’re on a mission to positively disrupt healthcare as we know it. Strive is about more than medicine. Strive is about striving for the personal side of healthcare.
Location: Onsite/ Hybrid Gilbert, AZ
Position Summary
The Director of Quality is responsible for providing enterprise-level leadership of Strive Pharmacy’s Quality Program. This role ensures excellence in quality assurance, quality control, and quality improvement across sterile and non-sterile compounding operations. The Director oversees the design, implementation, and continuous advancement of the Quality Management System (QMS), ensuring compliance with USP standards, FDA expectations, and state board of pharmacy regulations.
The Director of Quality sets the overall strategy for quality at Strive, partners with Compliance, Safety, and Operations leadership, and ensures a culture of quality is embedded across all sites.
Key Responsibilities
- Define and maintain Strive’s enterprise-wide Quality Management System (QMS), including SOPs, deviations, CAPAs, change control, and risk management.
- Establish strategic direction for QA, QC, and continuous improvement across all locations.
- Lead enterprise readiness for state board, FDA, DEA, and third-party inspections.
- Serve as the primary executive-level contact for regulators, accreditation bodies, and key external stakeholders on quality-related matters.
- Ensure ongoing compliance with USP <795>, <797>, <800>, FDA expectations, and all applicable state and federal pharmacy regulations.
- Oversee internal audit programs, quality metrics, and reporting systems to measure performance and identify trends.
- Direct the investigation and resolution of deviations, complaints, and quality-related events.
- Approve final quality decisions on high-risk matters impacting product integrity, patient safety, or regulatory compliance.
- Provide oversight of product testing, environmental monitoring, and documentation practices to ensure reliability and compliance.
- Guide continuous improvement initiatives that reduce risk, improve efficiency, and strengthen compliance culture across the organization.
- Ensure vendor qualification programs, raw material integrity, and supply chain quality controls are consistently applied.
- Oversee validation of packaging, shipping, and storage methods to ensure product stability and patient safety.
Qualifications
Education:
- Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Quality Management, or a related field required.
- Advanced degree (PharmD, Master’s in Regulatory Affairs, or Quality Management) strongly preferred.
Experience:
- 10+ years of progressive experience in pharmaceutical quality assurance and regulatory compliance, with at least 5 years in a senior leadership role.
- Direct experience in sterile and non-sterile compounding (503A and/or 503B environment strongly preferred).
- Demonstrated expertise in USP <795>, <797>, <800>, FDA expectations, DEA oversight, and state board of pharmacy regulations.
- Proven success in preparing for and managing state board, FDA, DEA, and third-party inspections.
- Strong background in developing and managing Quality Management Systems (QMS), including SOPs, deviations, CAPAs, risk assessments, and change control.
Skills & Competencies:
- Deep understanding of quality assurance, quality control, and quality improvement principles in a regulated environment.
- Familiarity with 21 CFR Part 11, data integrity standards, and electronic document control systems.
- Excellent leadership skills with experience mentoring QA teams and aligning multi-site operations under a unified quality program.
- Strong communication and problem-solving abilities with proven success in influencing cross-functional teams and external stakeholders.
- Ability to make final high-risk quality decisions that directly impact patient safety and regulatory standing.
Benefits/ Perks
Strive Pharmacy provides a comprehensive benefits package that encompasses various perks such as employer paid healthcare coverage available after 30 days of employment, the choice of an FSA/HSA, a voucher for new hire scrubs (if applicable), parental leave, a 401(k) plan with matching contributions, and the benefit of weekends and holidays off. FREE COMPOUNDED MEDS to employees and immediate family members.
Culture
At Strive, culture plays a fundamental role in shaping our workplace atmosphere. Beyond our exceptional benefits package, we foster a sense of community. Throughout the year, we arrange various holiday potlucks and festive celebrations. Strive is committed to promoting both personal and professional development, striving for our employees to excel and grow in every aspect of their lives, both within and outside of the workplace.
EEO
Strive Pharmacy is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristics as outlined by federal, state or local laws.
Disclaimer*** Please do not call the pharmacy location with questions about your application or interview. A talent acquisition partner will reach out to you.
