Director of Controlled Substance Compliance (Pharma)

Lead Compliance for Controlled Substances & Shape the Future of Safe Medication AccessThis Jobot Job is hosted by: Emily KlopfensteinAre you a fit? Easy Apply now by clicking the "Apply" buttonand sending us your resume.Salary: $180,000 - $190,000 per yearA bit about us:Are you a compliance expert ready to drive regulatory excellence in controlled substances? Join a pioneering healthcare leader committed to quality, innovation, and patient safety!We are a trailblazing healthcare organization dedicated to making high-quality, affordable medication accessible to millions nationwide. As the largest 503A compounding pharmacy and FDA-registered 503B outsourcing facility in the country, we prioritize People, Quality, Service, and Innovation in everything we do. Our vertically integrated approach to pharmaceutical manufacturing, distribution, and compliance ensures that we stay ahead of industry standards while improving patient outcomes.Here, we foster a culture of collaboration, innovation, and professional growth. If you're looking for a role where your expertise will drive meaningful change and where your contributions are valued, this is the place for you.Why join us?Make an Impact - Play a critical role in ensuring compliance with DEA and FDA regulations while protecting patient safety.Industry Leadership - Be part of an organization at the forefront of pharmaceutical innovation and regulatory excellence.Growth & Development - Expand your expertise with cutting-edge compliance strategies and AI-driven regulatory solutions.Comprehensive Benefits - Enjoy no-cost prescribed compounded medications, robust healthcare coverage, and onsite wellness perks like IV therapy drips.Work-Life Balance - Take advantage of flexible schedules, generous paid time off, and volunteer opportunities.Financial Security - Benefit from a 401K match up to 4%, life & AD&D coverage, and company-paid long-term disability insurance.Recognition & Support - Thrive in an environment where your contributions are celebrated through rewards programs and professional development opportunities.Job DetailsThe Director of Controlled Substance Compliance ensures strict adherence to federal and state regulations governing controlled substances. This leadership role is responsible for safeguarding compliance, mitigating risk, and fostering a culture of accountability while supporting access to safe and affordable medications.Key Responsibilities:Develop and implement comprehensive policies and procedures to ensure compliance with DEA and FDA regulations related to controlled substances.Lead internal audits and inspections to proactively identify and address compliance risks, driving continuous improvement in documentation and handling procedures.Collaborate with cross-functional teams"”including manufacturing, quality assurance, legal, and supply chain"”to integrate compliance strategies into daily operations.Manage and maintain all required licenses and registrations for controlled substances, ensuring timely renewals and adherence to regulatory obligations.Serve as the primary liaison with regulatory agencies, facilitating inspections, responding to inquiries, and resolving compliance issues to protect operational integrity.Required Knowledge and Skills:Strong leadership, decision-making, and collaboration skills with the ability to navigate complex regulatory environments.In-depth understanding of DEA and FDA regulations, with strong analytical abilities and proficiency in compliance management software and Microsoft Office Suite.Core Competencies:Customer Focus - Builds strong relationships and delivers customer-centric solutions.Optimizes Work Processes - Develops efficient workflows with a focus on continuous improvement.Collaboration - Works effectively across teams to achieve shared objectives.Resourcefulness - Identifies and deploys resources effectively.Manages Complexity - Analyzes complex information to solve problems effectively.Ensures Accountability - Holds self and others responsible for meeting commitments.Situational Adaptability - Adjusts approach based on evolving demands.Effective Communication - Tailors messaging to meet the needs of different audiences.Experience & Qualifications:Minimum of 10 years' experience leading compliance programs for controlled substances, with a strong track record of implementing regulatory strategies.Bachelor's degree in pharmacy, chemistry, business administration, or a related field; advanced degrees or compliance certifications preferred.Preferred certifications: CRCM, CCEP, CFE, DEA Diversion Awareness Certification.Experience utilizing AI-driven solutions to enhance efficiency, problem-solving, and regulatory decision-making.Interested in hearing more? Easy Apply now by clicking the "Apply" button.

Created: 2025-02-20