Director of Compliance
Director of Compliance Any Concordance location At Concordance Healthcare Solutions, we believe that each team member makes a difference...
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Tiffin, OhioOther County
- Subject matter expert, Directs projects, initiatives, regulatory sanctions, executive-sponsored initiatives, regulatory audits or exams, internal audits, accreditations, on-site reviews, risk assessments; audit planning, conducting mock audits, conducting audit training, managing audit evidence audit lead.
- Develops strategic plans, makes recommendations to leadership; designs/implements annual compliance plan. Develop strong relationships with key leaders to identify and address compliance risks and failures and manage action plans designed to fully mitigate risk(s).
- Managing the training for all VAWD inspections and six (6) VAWD locations.
- Ensure compliance to Code of Federal Regulations for cGMP, pharma storage and distribution, Recall Processing, HR3204 Drug Supply Chain Security Act and state Board of Pharmacy Laws.
- Work with cross functional management to ensure that all departments are trained and have a working knowledge of regulatory laws affecting wholesale drug and device distribution.
- Leads compliance monitoring to identify process gaps, validate compliance levels, map processes, draft corrective actions/remediation plans, oversee implementation of corrective actions, prepare reports/presentations.
- Directs audits of facilities and products for compliance with applicable regulations and industry standards
- Provides business leaders with timely communication on regulatory developments and updates, through presentations and key business platform and planning meetings
- Work with Finance, Contracts, and Accounts Receivable Departments to ensure that all requirements and forms for new account onboarding are accurate, received and maintained. Ensure that all required fields are completed and accurate to meet company goals.
- Oversee licensing for facilities, customers, and vendors.
- Oversee recall compliance process and work to streamline both internally, with vendor partners and key customer accounts.
- Work with item maintenance, receiving, inventory control to ensure all Drug Supply Chain Security (DSCSA) items are coded properly, documentation is received from vendors and that Concordance is processing the documentation timely and that all required documents are available on the web, as required by law.
- Travel required up to 25%.
- Other duties as assigned.
- This role is located in any Concordance location
- Bachelor’s degree or equivalent combination of education and experience
- 8-10 years of health care, regulatory, compliance or privacy experience
- Strong knowledge of the industry including knowledge of and experience with laws, regulations and industry guidance.
- Able to communicate effectively with leadership across the company.
- Strong leadership/managerial skills and ability to motivate/coach direct and indirect staff
- Strong communication skills
- Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice.
- Strong project and time management skills with the ability to handle multiple tasks, set priorities, meet deadlines, and develop process efficiencies where required.
- Demonstrated experience in handling confidential and sensitive situations and information with ability to exercise a high degree of judgment and discretion.
- Problem solving and solution based thinking are a must.
- Strong business ethics and impeccable integrity
- Must be able to successfully pass a pre-employment drug screening and background check.
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