Director of Compliance
$104k - $159kAfinida, Inc.
The Director of Compliance is responsible for overseeing the pharmacy’s day-to-day operations and ensuring compliance with all applicable federal, state, and local laws, regulations, licensing requirements, industry standards, and company policies. This position provides strategic and operational leadership to promote efficient, effective, and compliant pharmacy operations while managing regulatory requirements and maintaining the highest standards of quality and accountability.
This role owns the pharmacy compliance framework end to end, including multi-state pharmacy licensure and board relations, HIPAA and patient privacy compliance within pharmacy operations and adherence to applicable accreditation standards.
Supervisory Responsibilities:
- Supervise, lead, and develop pharmacy and compliance personnel, including setting goals, assigning responsibilities, providing feedback, and supporting professional development.
- Promote a culture of accountability, professionalism, patient safety, ethical conduct, and regulatory compliance.
- Collaborate with executive leadership, Legal, HR, Operations, and other departments to address operational and compliance matters.
- Provide regular reporting to executive leadership regarding pharmacy performance, compliance activities, regulatory developments, risks, audits, and corrective actions.
- Lead and maintain the company’s comprehensive compliance program, including policies, procedures, internal controls, audits, monitoring, and risk management.
- Ensure pharmacy operations comply with applicable federal and state requirements, including applicable Boards of Pharmacy, DEA, FDA, CMS, and other regulatory agencies.
- Monitor regulatory changes and ensure timely implementation of required operational and policy updates.
- Oversee compliance related to controlled substances, prescription processing, privacy, recordkeeping, medication handling, and other applicable pharmacy requirements.
- Conduct and oversee audits, inspections, investigations, risk assessments, and corrective action plans.
- Serve as a key resource to executive leadership and internal teams regarding pharmacy, healthcare, and regulatory compliance matters.
- Other duties may be assigned as needed by management;
- Working knowledge of the Anti-Kickback Statute, False Claims Act, and OIG guidance as applied to manufacturer patient assistance and free goods programs.
- Experience with multi-state pharmacy licensing and board of pharmacy relations.
- Familiarity with HIPAA privacy requirements in a pharmacy or healthcare operations setting.
- Experience with pharmacy accreditation standards (URAC or equivalent).
- Strong written and verbal communication skills, with the ability to translate regulatory requirements into practical operational guidance.
- Demonstrated ability to work cross-functionally with operations, legal, privacy, and executive leadership.
- Bachelor’s degree in Pharmacy, Healthcare Administration, Business, Compliance, or a related field; advanced degree preferred.
- 5+ years of experience in pharmacy operations, healthcare compliance, regulatory affairs, or a related field.
- Significant experience overseeing pharmacy operations and compliance in a regulated healthcare environment.
- Strong knowledge of federal and state pharmacy regulations, licensing requirements, and regulatory agencies.
- Experience with pharmacy audits, inspections, controlled-substance requirements, and regulatory compliance.
- Prior supervisory or management experience with the ability to lead, develop, and evaluate employees.
- Strong leadership, analytical, organizational, communication, and problem-solving skills.
- Ability to interpret regulatory requirements and translate them into effective operational policies and p rocedures.
- While performing the duties of this job, the employee may be regularly required to stand, sit, talk, hear, reach, stoop, kneel, and use hands and fingers to operate a computer, telephone, and keyboard.
- Specific vision abilities required by this job include close vision requirements due to computer work.
- Light to moderate lifting may be required.
- Regular, predictable attendance is required; including quarter-driven hours as business demands dictate.
- Moderate noise (i.e., business office with computers, phone, and printers, light traffic).
- Ability to work in a confined area.
- Ability to sit at a computer terminal for an extended period.
Salary Range:
- $104,000 – $159,000 annually
Disclaimer:
This Job Description is only a summary of the typical functions of the position or role, not an exhaustive or comprehensive list of all possible responsibilities, tasks, and duties. Additionally, responsibilities, tasks, and duties of the employee in this role might differ from those outlined in the Job Description and other duties may be assigned on a permanent or temporary basis based on business needs.
The Job Description is intended to be a general representation of the responsibilities and requirements of the job. However, the description may not be all-inclusive, and responsibilities and requirements are subject to change.
Equal Employment Opportunity
It is the policy of the Company to provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, sensory, physical, or mental disability, marital status, veteran or military status, genetic information, or any other classification protected by applicable local, state, or federal laws. This policy applies to all aspects of employment, including, but not limited to, hiring, job assignment, compensation, promotion, benefits, training, discipline, and termination. Reasonable accommodation is available for qualified individuals with disabilities, upon request.
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