Vice President, Compliance

2 weeks ago


Houston, United States Empower Pharmacy Full time

Position Summary:
The Vice President of Compliance at Empower is a critical leadership role, entrusted with architecting and executing a robust compliance framework that aligns with the complex regulatory landscape of the 503A and 503B industries. This executive, reporting to the General Counsel, is the cornerstone of ensuring that Empower's operations adhere to the rigorous standards set by regulatory bodies such as the FDA, DEA, OSHA, HIPAA, and State Boards of Pharmacy.

The essence of this role transcends traditional compliance oversight; it's about embedding a culture of integrity and ethical practice across all facets of Empower's operations. The VP of Compliance is tasked with developing and refining policies and procedures that meet regulatory requirements. This involves spearheading internal audits, fostering a proactive risk management approach, and implementing a comprehensive training program that empowers employees to uphold and advocate for Empower's commitment to compliance.

Collaboration is pivotal in this role. The VP will liaise with a broad spectrum of stakeholders, including vendors, clinics, and internal teams, to ensure that compliance strategies are effectively integrated and responsive to the needs of our diverse partnerships. This requires a nuanced understanding of the regulatory environment, an ability to anticipate and adapt to regulatory changes, and a strategic mindset to navigate challenges and opportunities that arise.

Duties and Responsibilities:

- Works with vendors and clinics to ensure that the compliance program meets the needs of the partnerships, with a focus on quality compliance, prescriber licensure compliance, pharmacy compliance, controlled substance inventory count, and records management.
- In conjunction with the General Counsel, develops and implements policies and procedures to ensure compliance with federal and state regulatory rules and regulations governing commercial matters.
- Creates standard operating procedures (SOP’s) for audits, disseminates audit findings, develops a compliance workplan, and gains buy in from leadership to achieve compliance goals.
- Assists in building and executing the enterprise-wide compliance training and audit program.
- Interacts with the Board and the Committees of the Board to ensure that all are adequately informed on the Company’s compliance matters.
- Ensures pharmacy labeling, shipping, and manufacturing compliance in all jurisdictions.
- Manages relationships with regulators including the FDA, DEA, and Boards of Pharmacy in all 50 states.
- Assists in investigations related to the Company’s compliance program, following through on rectifying issues identified during the audit process.
- Revises and implements privacy policies for the Company as domestic and international regulations evolve, ensuring patient communication processes satisfy state, federal, and DEA requirements and breach of privacy incidents are addressed appropriately.
- Scales the existing compliance team to support growing business needs.
- Responds to and addresses alleged violations of rules, regulations, policies, and procedures by assisting in investigations, informing executive management and the Board, and recommending the necessary actions to prevent further violation.
- Monitors the state, federal and international legislative landscape to stay informed on proposed laws, rules, and regulations that the Company must follow.
- Reviews and interprets the proposed new laws or rules and regulations and provides frequent updates and summaries to executive management and the Board on identified risk areas or red flags, setting a tone of compliance at the top.
- Establishes and chairs a compliance committee to periodically evaluate the effectiveness of the Company’s compliance program and any alleged violations of such program.
- Ensures proper reporting of violations to duly authorized enforcement agencies as appropriate or required.
- Fosters a creative and collaborative work environment, encouraging teamwork, professional growth, and knowledge sharing among team members.
- Monitors and evaluates employee performance. Provides constructive feedback as necessary.
- Performs other duties as assigned.

To perform this job successfully, an individual must be able to perform each essential function satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions.

While performing the responsibilities of the job, the employee is required to talk and hear. The employee is often required to remain in a stationary position for a significant amount of the workday and frequently use their hands and fingers to handle or feel in order to access, input, and retrieve information from the computer and other office productivity devices. The employee is regularly required to move about



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