Job Title: Compliance Manager
Employment Type: Full Time
Job Posted Date: December 16, 2019
PREFERRED EXPERIENCE: Experience with Board of Pharmacy, and/or VAWD, FDA, DEA, Change Management, Metrics, Analytics and Action Plans
ROLE OVERVIEW: The Compliance Manager is responsible oversight and ownership to ensure the companies are meeting regulatory and compliance pharmaceutical standards.
RESPONSIBILITIES: This role is responsible for our client wholesale distribution and Crosswind Pharmacy, LLC closed-door home delivery pharmacy licensure, compliance/regulatory, and quality initiatives.
REQUIRED EDUCATION: Associate’s Degree Required; Bachelor Degree Preferred
The following functions describe the essential duties of this role. Individuals in this role may not perform all of these duties, or may perform additional, related duties not listed here.
• Maintains company Standard Operating Procedures (SOP), including reviews and updated every 2 years and necessary ongoing updates due to process or regulatory changes. Creates, augments and sunsets SOPs as needed.
• Responsible for ensuring company process and procedures follows SOP.
• Primary contact for regulatory bodies including, but not limited to, VAWD, FDA, DEA, Board of Pharmacy.
• Maintains accurate and organized systems for regulatory bodies and owns all preparation and follow-up for any visits.
• Creates, maintains, and is proactive in managing licensure for the company including renewals and the addition of new states.
• Creates and manages efficient recall process focusing on regulatory requirements and provides excellent customer communication.
• Responsible for management of repackaging including processes, SOP, regulations, and executing repackaging when needed.
• Responsible for training team members on SOPs and procedures
• Ensures compliance communication across all businesses is efficient and clear.
• Assists in executing fulfillment when needed, including working in the warehouse.
• Responsible for regulatory reporting within the defined periods.
• Identifies and mitigates single points of failure.
STANDARDS OF BEHAVIOR:
• Excellent customer care and focus; ability to assess customers’ needs and provide correct answer, path, troubleshooting, or method for a positive customer experience.
• Able to think fast, find answers, and respond quickly to customer issues, all with a polite, empathic, and professional voice and manner.
• Able to multitask, prioritize, and manage time efficiently.
• Encouraging to team and staff; able to mentor and lead.
• Able to analyze data and sales statistics and translate results into better solutions.
• Excellent verbal and written communication skills.
• Self-motivated and self-directed.
• Excellent time management and prioritization skills.
• Responds to internal and external communication same-day.
• Displays ownership of role including ensuring self and those that have been delegated to have completed necessary steps to meet task or goal.
• Must pass pre-employment background check and drug screen
• Frequent lifting of 15-60 pounds
• Punctual and reliable in attendance
1. Business Acumen
3. Regulatory Expertise
4. Mitigate Risk
5. Ethical Practice
6. Best Practice Champion
7. Procedure Writing
8. Customer Care
• VAWD, DEA, FDA: 1 year (Preferred)
• Pharmacy Board: 1 year (Required)
Pharmacy Board, VAWD, DEA and Controlled substances regulatory compliance. Managed nation-wide state licensure. Analytic reporting, managed within a closed door pharmacy as a compliance and/or quality manager. Process implementation, HIGH attention to detail and auditing.