Job Description
Job Description
Summary
The Compliance Director will be responsible for compliance oversight across APG, developing compliance strategies, conducting risk assessments and compliance audits, managing risk, and ensuring that all pharmacy operations align with industry standards and best practices. This role will play an active and integral part in ensuring adherence to federal, state, and local regulations as well as internal APG policies. The Compliance Director collaborates with leadership, the legal team and regulatory agencies to maintain the highest level of compliance and patient safety.
Duties and Responsibilities
They include the following and other responsibilities may be assigned as needed :
Regulatory Compliance & Oversight :
- Ensure operations comply with federal, state and local regulations, including but not limited to FDA, DEA, CMS, HIPAA and state pharmacy boards.
- Monitor changes in laws and regulations, updating policies and procedures accordingly.
- Manage all compliance-related inquiries, inspections, and audits.
Policy Development & Implementation :
Develop, implement, and maintain pharmacy compliance policies, standard operating procedures (SOPs), and Code of Conduct & Ethics.Educate staff on regulatory requirements, ethical standards, and internal policies to ensure proper adherence.Conduct regular risk assessments and implement mitigation strategies.Collaborate with other APG departments to support the employee training program.Audits & Investigations :
Lead internal audits to assess compliance and identify areas for improvement.Investigate compliance violations, document findings, and implement corrective action plans.Maintain accurate records and reporting mechanisms for compliance-related matters.Training & Education :
Develop and conduct compliance training programs for pharmacy staff, ensuring awareness of laws,regulations, and company policies.Foster a culture of compliance and ethical behavior within the organization.Collaboration & Leadership :
Work closely with pharmacy leadership, legal counsel, and quality assurance teams to develop and maintain compliance frameworks.Act as a compliance advisor to pharmacy operations, providing guidance on risk mitigation and best practices.Participate in strategic decision-making to align compliance initiatives with business goals.Controlled Substance Compliance :
Oversee compliance with DEA regulations, including controlled substance handling, storage, and record-keeping.Implement safeguards to prevent drug diversion and ensure accurate reporting.Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and / or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
Bachelor’s degree in pharmacy, Regulatory Affairs, Accounting, or a related field (PharmD preferred).5 years of experience in pharmacy compliance, regulatory affairs, or a related field.In-depth knowledge of federal and state pharmacy regulations, including DEA, FDA, CMS, and state pharmacy boards.Experience conducting audits, risk assessments, and investigations.Juris Doctor is a plus.Knowledge, Skills and Other Abilities
Strong leadership, analytical, and problem-solving skills.Excellent communication and ability to work cross-functionally with various departments.Ability to read, analyze, and interpret governmental regulations, general business periodicals, professional journals, or technical procedures required.Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required.Ability to write reports, business correspondences, complete applications, and procedures required.Ability to effectively present information, deliver training, and respond to questions from groups of colleagues, managers, partners, and customers required.Ability to demonstrate critical thinking is required.Ability to manage multiple projects and deadlines.Ability to work independently on tasks.Proficiency in MS Office applications required.Travel up to 25% domestically for regulatory inspections, audits, and compliance training.Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to walk; sit and use hands. The employee is occasionally required to stand.
