Job Description

Director of Quality Assurance and Regulatory Compliance - Compound Pharmacy

Position Summary:

You will love it here if you are motivated by our Core Identity Values:

• Excellence Always
• Go-Getters Unite
• Compassion For All
• Called To Serve

Qualifications and experience:

• Bachelors degree in Pharmacy, Chemistry, Biology, Regulatory Affairs, or a related field required.
• PharmD or Masters degree in Regulatory Science, Pharmaceutical Quality, or related discipline strongly preferred.
• Minimum 7 years of experience in quality assurance or regulatory compliance within a compounding pharmacy, sterile manufacturing, or pharmaceutical setting.
• Experience in both 503A and 503B environments is highly desirable.
• Demonstrated leadership experience, including direct team management, cross-functional collaboration, and accountability coaching.
• In-depth knowledge of applicable FDA regulations, USP Chapters <795> , <797> , <800> , 21 CFR Part 210/211, and DEA regulations.
• Proven experience leading regulatory audits and inspections, including writing effective 483 responses, CAPAs, and executing remediation plans.
• Expertise in managing state board licensing, DEA registration, and pharmacy accreditations (e.g., NABP, PCAB, URAC).
• Working knowledge of stability studies, environmental monitoring, and QC release programs.
• Strong documentation and SOP writing skills; experience implementing and maintaining eQMS platforms preferred.
• Exceptional communication skills, with the ability to clearly articulate regulatory concepts to internal teams and external regulators.

Youll have success here if you are excited about the following key responsibilities:

Leadership + Management = Accountability

• Provides their team with 5 Leadership practices and 5 Management practices creates the environment where the byproduct is Accountability.
• Leads using the 5 leadership practices of giving clear direction, providing the necessary resources for success, letting go of the vine via effective delegation and coaching, acting for the greater good, and taking clarity breaks to create space for strategic thinking.
• Manages using the 5 management practices of keeping expectations clear (responsibilities, metrics, goals), open communication via frequent check-ins, holding consistent and effective meetings, promptly addressing issues head-on, and recognizing and rewarding positive behaviors.

Regulatory Compliance & External Communication

• Serve as the primary point of contact with the FDA, state pharmacy boards, NABP, and accrediting bodies, ensuring all regulatory requirements are met.
• Lead regulatory reporting, inspections, and responses while proactively staying ahead of industry changes.
• Maintain strong relationships with external agencies to support compliance and business growth.

Licensing & Accreditation Management

• Oversee and drive pharmacy and personnel licensure in all operational states, ensuring timely renewals and compliance documentation.
• Lead efforts to obtain and maintain key accreditations such as NABP, PCAB, URAC, and DEA registrations, while preparing the organization for potential 503B expansion.

Quality Control, Quality Assurance & Continuous Improvement

• Implement and oversee stability programs and release testing, ensuring uncompromising quality control in all compounded medications.
• Track and manage quality metrics, deviations, CAPAs, and QREs, using data-driven insights to improve processes and prevent compliance risks.
• Strengthen SOPs and enforce adherence to USP, cGMP, and industry best practices.

Internal Training & Quality Culture Development

• Develop and implement a turnkey training program to ensure all employees understand and follow compliance and quality protocols.
• Embed a culture of accountability and quality excellence across all departments, reinforcing best practices in pharmacy operations, regulatory compliance, and customer service. Conduct routine audits and assessments to ensure ongoing adherence.

Benefits & Perks:

• Comprehensive Medical, Dental, and Vision Options : Choose from three medical plans tailored to your needs, plus options for dental and vision coverage for you and your family.
• Paid time off (vacation and sick time): Take advantage of generous paid time off to recharge, focus on personal priorities, and maintain a healthy work-life balance.
• Paid Holidays (8 scheduled): Enjoy eight scheduled paid holidays to celebrate and spend quality time with loved ones.
• 401K Dollar-for-Dollar Up to 4%: Invest in your future with our 401K plan, featuring a dollar-for-dollar match up to 4%.

Rewards & Recognition Program: Be celebrated for your hard work and achievements through our dedicated rewards and recognition program.

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