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Director of Pharmacy Governance and Quality

Departments: Operations
Locations: Oak Brook , IL

COMPANY BACKGROUND & CULTURE

A national digital pharmacy, OptioRx, is focused on providing best-in-class patient care in niche therapeutics.  These therapies include compound custom medications for humans and animals, in the areas of fertility, home-infusion, and hospice. Headquartered in Oakbrook, Illinois, we are a national provider where we service (serve) 48 states and Washington D.C.  The OptioRx mission is to create and provide the highest quality care for patients by offering a broad range of pharmaceutical therapies. We are a committed partner to both patients and providers and are continually innovating.  Our commitment to patient care results in improved access and speed to therapy by offering services via our proprietary technology and accredited pharmacies.

At OptioRx we value team members with a committed confidence that supports our Core Values. Empowered – put trust in our people and empower them to succeed. Innovative – offer innovative solutions that target growth and scale of OptioRx on a national stage. Efficient – drive efficiency by creating economies of scale and expertise. Accountable – own our commitments and quality of our work, while holding ourselves accountable to drive real results. Ethical – ensure unwavering integrity and business ethics. Energy – move fast with a sense of urgency and honest communication.

Position summary

The Director of Pharmacy Governance and Quality will work cross functionally with all OptioRx departments and stakeholders to lead, monitor, support and promote regulatory, safety policies and procedures, and accreditation standards across the Company. This position actively provides leadership, direction, technical expertise as well as compliance to the Company’s quality assurance program in accordance with USP, state and federal regulatory agencies, and third-party payers. The Director of Pharmacy Governance and Quality will report directly to the Chief Pharmacy Officer.

Essential functions

  1. Lead the creation, maintenance and implementation of standard policies, procedures and best practices across the organization to promote compliance with applicable state and federal laws, regulations, USP standards, contractual obligations, and OptioRx policies, procedure and expectations.
  2. Develop compliance communications and cadence that fosters a compliance culture, emphasizing risk mitigation and problem resolution.
  3. Support cross functional working relationships across the enterprise; in particular, collaboration with corporate and field operations to assess, review, analyze, create and support implementation of compliance/governance project plans and related initiatives, such as corrective action plans and accreditation requirements.
  4. Remains current with pharmacy regulatory standards, affecting immediate day-to-day operations, and OptioRx’s long term goals, vision and strategy; specifically related to state BoPs, FDA, DEA, CMS and various accrediting and certifying bodies (ACHC, PCAB, VPPS, URAC, etc.)
  5. Leads and oversees Pharmacy Governance and Quality department based on qualitative and quantitative information and data, while adhering to department’s budget and Company’s financial expectations.
  6. Integrate into the Company’s culture and support the Core Values to ensure a positive work environment that enables OptioRx to attract, retain and motivate high-performing employees.
  7. Consult and coordinate with Operations, Sales, Marketing and Program Development to ensure all current and new OptioRx products and programs being offered in the marketplace adhere to all regulations and related requirements.
  8. Support achievement of new and maintenance/renewal of current pharmacy accreditations and certifications (i.e. ACHC, HQAA, VPPS, JCAHO).
  9. Develops training programs and supports implementation of employee education and training necessary to create strict adherence to corresponding policies and procedures.
  10. Integrates into and supports the Company’s culture, ensuring a positive work environment that enables OptioRx to attract, retain, and motivate high-performing employees.
  11. Be the leader for business both internally and externally – solicit/value employees’ perspectives and recruit quality talent.
  12. Directly and indirectly conduct pharmacy surveys, gap analyses and related risk assessments to ensure compliance and safety; communicates findings and collaborates with operations, related functional areas, and site-level stakeholders to address gaps, deficiencies, and areas of risk.
  13. Anticipates potential risk areas within pharmaceutical integrity for the organization, develops and implements processes to mitigate the risk of fines, penalties and litigation taking place.
  14. Develop, implement and lead OptioRx’s Quality Assurance Program. Manages the evaluation of quality events, incidents, and complaints; ensures proper documentation, investigation, and action plans of all quality enhancement improvements.
  1. Oversees current correction action plans and works closely with operations and site leadership to create new corrective action plans as needed.
  2. Document and maintain project plans and status reports as related to compliance programs, mock inspections, gap analysis, audits, and other ad hoc initiatives as needed; prepares and presents reports, executive summaries, and related presentations on a routine basis.
  3. Directs and coordinates unique investigations involving controlled substance ordering and dispensing, which may involve highly sensitive and/or extremely confidential information; advises and counsels executives and others in matters and related issues impacting or potentially impacting the Company.
  4. Possess executive presence, effective communication skills, verbal and written; provides proactive leadership, motivates team members, and ensures the right tools and resources are in place for success.
  1. Hold an unquestioned level of personal and professional integrity, ethics, and exhibits excellent interpersonal skills.
  2. Other duties as assigned by OptioRx

Qualifications

  1. Bachelor of Science in Pharmacy or Doctor of Pharmacy Degree
  2. Formal regulatory, compliance and/or quality training/certifications (i.e. RAQA, cGMP, CAPA)
  3. Previous accreditation experience is preferred

Professional Experience:

  1. Minimum of 5 years’ experience in pharmacy compliance role; retail, compounding, and/or specialty settings a plus.
  2. Proven track record in recruiting, hiring, leading, coaching, building successful teams, and developing leaders
  3. Commitment to continuous process improvement, background in Lean Six Sigma principles preferred.
  4. Experience in core elements of pharmacy and business operations, in particular governance, policy and procedure creation and management, safety and risk management
  5. Ability to balance multiple projects and adapt to new issues/assignments as business needs change
  6. Self-starter that takes ownership and an inventive problem solver with a high level of personal and team accountability
  7. Operates with the highest level of ethics, compliance, professionalism, and integrity
  8. Proficient in reading, writing, and implementing SOPs consistent with corresponding regulatory bodies, payer entities, and company policy and expectations
  9. Extensive experience auditing processes, conducting gap analyses, and making corresponding SOP changes to ensure compliance
  10. Flexible, able to respond to incidents based on urgency and priority, multitask oriented

Licenses/Certifications

  1. Valid and active pharmacist license in corresponding state(s), multiple states an advantage

Specialized Skills

  1. Minimum 5 years’ experience managing compliance for a retail, specialty, and/or compounding pharmacy
  2. Vast knowledge of state, federal, payer, and related entity’s regulations, statutes, laws, and requirements
  3. Extensive experience creating, implementing, and managing a comprehensive compliance program across multiple units; HIPAA/HITECH, FWA, QA, CMS, USP <795>, <797>, and <800> standards
  4. Experienced and comfortable navigating regulatory audits and responses, in particular state BoPs, FDA, DEA, and CMS
  5. Substantial experience writing, implementing, and maintaining a pharmacy policy and procedure manual
  6. Direct experience working in a 503A and/or 503B compounding pharmacy
  7. Firm understanding and experience with pharmacy accreditation, compliance, and remediation; this position would be responsible for the implementation and/or maintenance of ACHC, URAC, PCAB or related accreditation(s)
  8. Extensive knowledge of PBM contracts, reimbursement, compliance, and ability to navigate audit appeal/defense process
  9. Experience interacting with and responding to pharmacy and healthcare regulators, surveyors, and auditors; in particular, state BoPs, DEA, FDA, CMS, accreditation surveyors
  10. Proven ability to craft and implement, monitor, manage, and report performance of corrective action plans across multiple pharmacy locations
  11. Understands the value of, embraces, and supports a culture of continuous process improvement
  12. Understanding of pharmaceutical supply chain and necessary regulations and areas of compliance
  13. Strong ability to collaborate with stakeholders across the organization to include Pharmacy Business Development, Corporate Strategy and Development, Pharmacy Analytics and Reporting, Finance, Product Development, Sales and Marketing, and vendor relations
  14. Experience managing a metric driven department, using data and business analytics to make sound decisions and drive change

Technical Skills

  1. Underlying skills that enable an employee to perform effectively on the job
  2. High degree of proficiency MS Office Suite (Excel, Word, PPT), Outlook & internet applications
  3. Must have excellent communication skills, both written and verbal, and experience with communication at an executive level, small to midsize groups
  4. Strong analytical, prioritizing, interpersonal, problem-solving, budgeting, project management (from conception to completion), & planning skills
  5. Experience working with project management tools, such as Asana or Monday.Com, is highly preferred

Successfully pass background check prior to employment

Physical Requirements

  • Ability to continuously sit for extended periods of time.
  • Ability to bend or squat occasionally.
  • Ability to lift up-to 30 pounds occasionally.

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