Manager of Quality and Regulatory Affairs

OrderlyMeds • Riverview, FL

4d

About The Position

SmartPharmaRx is a 503A compounding pharmacy that has grown significantly over the past few years and is operating at a scale that demands exceptional people in every function. We are a close-knit, collaborative team that holds ourselves to a high standard, not because we have to, but because we genuinely care about the quality of what we produce and the patients who depend on it.
This is an environment where your work is visible, your expertise is respected, and your contributions shape how the organization grows. We invest in our people and we take the long view on building a team that is both excellent and sustainable.
The Manager of Quality & Regulatory Affairs is a senior leadership position responsible for the full scope of quality and regulatory function across our 503A compounding operations. Reporting directly to the Pharmacist-in-Charge, this role owns our Quality Management System, leads all regulatory relationships and inspections, and ensures the systems and culture are in place for the organization to scale with confidence and compliance.
This is a builder’s role. You will have the authority and the resources to establish best-in-class quality and regulatory practices, and a team that looks to you to set the standard.
You are a subject matter expert who leads with conviction. Your knowledge of quality and regulatory systems is deep, and you communicate it clearly and credibly. You set a tone of accountability while fostering a team culture that is positive, collaborative, and built on mutual respect. People enjoy working with you, and that matters as much to you as getting the work right.
You are self-directed and bring structure to ambiguity. You see gaps before they become problems and address them with solutions rather than escalation. Equally important, you understand that compounding pharmacy is a nuanced regulatory environment that often requires unique solutions. You exercise sound professional judgment, identifying practical and defensible paths forward without unnecessary friction. You know when to hold the line and when flexibility serves both the business and the patient, and you can tell the difference.

Requirements

• Graduate-level scientific degree
• Minimum 5 years of progressive experience in 503A or 503B compounding, pharmaceutical manufacturing, or outsourcing facility operations
• Deep working knowledge of USP <797>, <800>, <795>, and applicable FDA regulations governing compounding pharmacies
• Proven experience leading state board inspections, FDA observations, and accreditation audits (PCAB or equivalent) from preparation through closeout
• Strong working knowledge of aseptic processing principles, cleanroom design and operations, and environmental monitoring
• Demonstrated experience building or significantly improving a Quality Management System in a regulated environment
• Experience managing deviations, CAPAs, change control, complaints, and OOS investigations
• Excellent written and verbal communication skills, including regulatory writing and executive-level presentation
• Proven ability to lead and develop cross-functional teams
• Experience with QC laboratory oversight, instrument qualification, and method validation
• Familiarity with supplier qualification, COA review, and raw material release processes

Nice To Haves

• Experience in technology or automation integration within a pharmaceutical or compounding environment is a plus

Responsibilities

• Serve as the primary regulatory contact for FDA, state boards of pharmacy, and all applicable regulatory authorities, in close collaboration with the Pharmacist-in-Charge
• Oversee all license renewals, registrations, and regulatory filings across jurisdictions
• Monitor and interpret changes to FDA guidance, USP chapters, state pharmacy regulations, and DEA requirements as applicable
• Lead preparation and response for state board inspections, accreditation audits, and FDA observations — from readiness through corrective action closeout
• Provide proactive regulatory guidance to leadership on facility changes, process modifications, new product introductions, and expansion
• Manage outside regulatory counsel and consultants as needed
• Own and continuously improve the Quality Management System across all compounding operations, including system selection and implementation
• Oversee environmental monitoring, aseptic process simulations, and personnel qualification programs
• Manage deviations, OOS results, complaints, CAPAs, change control, and recalls
• Ensure qualification and validation of vendors, facilities, equipment, and critical processes
• Oversee batch record review and release programs
• Ensure BUD assignments are scientifically justified and compliant with applicable USP standards
• Lead internal audit programs to maintain constant inspection readiness
• Maintain QC oversight including testing protocols, instrument qualification, and method validation
• Partner with the Pharmacist-in-Charge and pharmacy operations to ensure compliant, efficient compounding workflows
• Manage document control systems for SOPs, batch records, master formula records, and validation protocols
• Ensure robust training and competency programs for all compounding personnel
• Provide quality input on new product development, formulation changes, and scale-up activities
• Collaborate with supply chain on supplier qualification, COA review, and raw material release
• Support technology and automation integration from a quality and compliance perspective
• Build, lead, and develop the QA/RA team with clear expectations and a culture of continuous improvement
• Establish quality metrics and dashboards that provide leadership with clear visibility into compliance performance
• Represent the quality function in executive discussions and strategic planning
• Develop and maintain a regulatory roadmap aligned with the company’s growth strategy

Benefits

• Benefits include medical, dental, and vision coverage with strong employer contribution, FSA and HSA options (with potential employer contributions), a 401(k) with company match, generous paid time off, paid parental leave, mental health and family-planning support, and access to professional development resources.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager