Compliance Manager

Concordance Healthcare Solutions LLC
vision insurance, long term disability, 401(k), retirement plan, profit sharing
United States, Ohio, Tiffin
85 Shaffer Park Drive (Show on map)
Jan 11, 2025
Description 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 900 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 for a full-time Manager of Compliance Pharmacy and Licensing (Classification title: Compliance Manager) in any Concordance location. The primary role of the Compliance Manager is to be responsible for overseeing the company's compliance with federal, state, and industry regulations, ensuring all business operations are conducted in accordance with regulatory standards. This includes managing compliance projects, providing training, and supporting the development of compliance-related processes across the company. Essential Functions: Responsible for developing, implementing, and maintaining companywide policies and procedures that align with federal and state regulations, as well as accreditation standards such as VAWD, DSCSA, and NABP. This role requires a thorough understanding of the company's business processes and an ability to translate regulatory requirements into clear, actionable guidance for employees. By working closely with department heads, the Compliance Manager will ensure that all employees, particularly those in sales and operations, are well-versed in compliance processes and how they relate to daily operations. Additionally, the manager will lead the company's quality improvement efforts by implementing a quality program that ensures process monitoring, progress tracking, and continuous improvement. The successful execution of these tasks is critical to ensuring the company remains compliant with evolving regulatory standards while maintaining efficient business operations. Monitor, review, and interpret regulatory updates from federal and state agencies, including VAWD, DSCSA, and NABP requirements. Provide regulatory recommendations and training to various departments. Lead internal and external audits, including regulatory inspections (FDA, Board of Pharmacy), and develop corrective actions/remediation plans. Conduct mock audits, manage audit evidence, and ensure timely follow-up on compliance findings. Design and manage compliance training programs for employees, particularly on VAWD/DSCSA regulations, FDA inspections, and Board of Pharmacy laws. Train operations managers on designated rep requirements. Oversee the licensing process for facilities, customers, and vendors. Manage the recall compliance process, ensuring efficiency both internally and with external partners. Ensure all requirements for onboarding new accounts are met, including accurate completion of forms and compliance with regulatory requirements. Conduct transactional monitoring, identify trends, and provide reports to executive leadership on compliance-related activities. Oversee and validate all compliance processes to ensure adherence to regulations. Support large-scale projects by developing business requirements, providing documentation, managing communication across teams, and tracking project progress. Manage HIPAA-related processes, including the review of new accounts for BA agreements, and lead companywide HIPAA training. Collaborate with the CFO to develop business continuity strategies and ensure processes are in place to maintain compliance in emergency situations. Oversee compliance for facilities and ensure processes are consistent and aligned with federal laws, such as the Drug Supply Chain Security Act (DSCSA). Provide timely communication to leadership on compliance updates. Oversee quality-related projects, including emergency readiness contracts and ensure compliance with ASPR (Assistant Secretary for Preparedness and Response) standards. Act as the Quality Director for the emergency readiness contract, ensuring compliance with cGMP pharma storage and distribution regulations. Oversee 3PL (Third-Party Logistics) licenses to ensure compliance with regulations. Collaborate with the Operations team to align compliance efforts and streamline processes. Work closely with the Legal and HR department to address compliance requirements and support licensing processes. Up to 15% travel or as needed for inspections and audits. Performs other duties as assigned. The above is intended to describe the general content of and requirements for the performance of this position. It is not to be construed as an exhaustive list or statement of duties, responsibilities or requirements. What You will Need to be Successful: Bachelor's degree in Business, or a related field or equivalent combination of education and experience. MBA or equivalent advanced degree preferred. Minimum of 5-8 years of experience in healthcare regulatory compliance, including at least 4 years in pharmacy compliance or privacy. Strong understanding of relevant laws and regulations (e.g., VAWD, DSCSA, NABP, Board of Pharmacy laws). Strong project management skills and the ability to handle multiple tasks with competing deadlines. Proven leadership and managerial skills, with the ability to motivate and coach direct and indirect reports. Excellent communication skills, both written and verbal, with the ability to present regulatory updates clearly. High degree of integrity and strong business ethics. Experience handling confidential and sensitive information. Successfully pass a pre-employment (post offer) background check and drug screening. Work Location: This role is located in any Concordance Location. This is a hybrid position. We offer great benefits and competitive pay! Health, Life, Dental, Vision Insurance Paid Vacation and Personal time, Paid Holiday 401K Retirement Plan - Company match Company paid Short Term & Long Term Disability Profit Sharing Program Concordance Healthcare Solutions, LLC is committed to being the most respected, innovative, national, multi-market healthcare solutions company earning the highest level of trust by operating with integrity, unwavering commitment and exceptional service through our culture of excellence. Through our dedicated staff of over 1,000 employees, working in strategically-located distribution centers across the country, we offer dynamic supply chain solutions to the entire healthcare continuum. Concordance Healthcare Solutions is proud to provide Equal Employment Opportunities to all individuals for employment and prohibits any kind of discrimination on the basis of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Consistent with the Americans with Disabilities Act, our organization is committed to providing reasonable accommodation to qualified applicants and employees as requested. If reasonable accommodation is necessary for the interview process, please contact vbrokate@concordancehs.com. Position will remain open until filled. Interested applicants should apply on-line at http://www.concordancehealthcare.com/careers. Internal employees should apply on-line through UKG Pro by selecting Menu > Myself > My Company > View Opportunities Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)