Manager of Quality and Regulatory Affairs

Manager of Quality and Regulatory Affairs About Orderly Wellness

Orderly Meds is a nationwide telehealth platform redefining how people access modern wellness care. We provide personalized, evidence based treatment, including GLP 1 prescription programs, easy to start and simple to manage from home, with transparent pricing, virtual consults, and medications delivered directly to patients’ doors. Our approach prioritizes quality, individualized care and ongoing support, from clinically guided treatment plans to nutrition, fitness, and mental health resources, without the barriers of insurance or traditional in office visits.

We are growing quickly and building a team that is passionate about creating a more accessible, patient centered healthcare experience.

Smart Pharma Rx  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.

• 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…