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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, Ohio

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Job Description

Director of Compliance
Any Concordance location
At Concordance Healthcare Solutions, we believe that each team member makes a difference in driving our purpose of positively impacting lives forward.  Concordance is committed to our guiding principles of financial stewardship, accountability, forward thinking, aligned relationships and an inclusive culture. This is done through maintaining an unwavering amount of respect and commitment with our employees and customers, being authentic to who we are and operating with the highest levels of integrity. Through our dedicated staff of over 1,200 employees, working in strategically-located distribution centers across the country, we offer dynamic supply chain solutions to the entire healthcare continuum.
We have a job opening and exciting opportunity for a full-time Director, Compliance in any of our Concordance Healthcare Solutions locations. The primary role of the Director, Compliance position is to have a comprehensive understanding of Concordance’s business operations, a widespread understanding of the laws and regulations surrounding wholesale drug distribution and to provide regulatory recommendations to the executive leadership team and guidance to the company. To develop and support compliance team members to fully understand company processes and how laws and regulations affect our business to ensure safeguards are in place and maintained.  Establish expectations, service levels, and requirements for each compliance position. Support sales and operational leadership with regulatory guidance and support for new programs, locations, and systems to ensure adherence to regulations.
What You Will Do:
  • 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.
Work Location:
  • This role is located in any Concordance location

Job Requirements

What You will Need to be Successful: 
  • 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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