Director, Quality
6 days ago
The Director, Quality & Regulatory, is responsible for assuring that the highest quality standards are met & maintaining a strong quality and regulatory adherent culture; monitoring and reporting on compliance results; providing guidance on matters relating to quality in all lines of business; and ensuring that all Medvantx adherence parameters to policies and procedures are in place Medvantx employees to comply with the quality rules and regulations of federal and state regulatory agencies. The Director, Quality & Regulatory is responsible for ensuring the implementation of quality assurance operating procedures, ensuring the completion of quality assurance/quality improvement assessments monthly, and monitoring quality improvement/quality assurance outcomes. The Director of Quality & Regulatory reports directly to the VP, Medical Affairs.
Key Responsibilities
- Coordinate with commercial, operations, pharmacy, supply chain, legal, IT and other teams to ensure that compliance processes for various functions (such as item setup, pricing, logistics, online catalog and content and other eCommerce services) address legal and compliance requirements, including requirements from certain agencies (such as FDA, FCC, FTC, EPA, local State AGs, Accreditation bodies, etc.)
- Coordinate and lead the activities of the Medication Safety Committee and subcommittees, including monitoring and analyzing adverse drug events (ADEs).
- Prioritize and review best practice guidelines & quarterly action agendas, conduct gap analyses, and develop action plans as needed for relevant areas.
- Review investigations and conduct CAPAs in adherence with pharmaceutical manufacturer requirements
- Lead root cause analysis and other performance improvement methods to enhance patient safety.
- Monitor medication safety benchmarks and proactively assess risks across the medication use & fulfillment process.
- Stay informed about current trends and developments in medication safety through ongoing education.
- Maximize efficiency of risk assessments in a constantly evolving environment.
- Develop and maintain standard operating procedures in adherence with local and federal regulatory requirements
- Create and monitor quality & regulatory KPIs to identify potential program risk; define long-term goals to help bolster trust among clients, partners, and customers.
- Interface with external quality, compliance, and audit teams at partnering organizations.
- Strives for uniformity throughout policies and procedures, written communication, and forms.
- Participate in the tracking, preparation and submitting of federal, state, and local required forms and information to comply with accreditation bodies, licensing bodies, and other governing standard bodies to meet requirements, and ensure that all filings are accurate and timely.
- Continuously seek, learn, and apply knowledge regarding governance and associated rules, regulations, best practices, tools, techniques, and performance standards.
- Review audits and ongoing monitoring of DEA compliance, FDA compliance, PDMP compliance, OSHA compliance, HIPAA and HITECH compliance, and Boards of Pharmacy regulatory compliance, and compliance with client KPIs.
- Partner with the CCO to the design and maintenance of quality programs, including but not limited to QA plans, inspection procedures, work instructions, training, deviation investigations and CAPA management, facility mapping and validation projects.
- Follows, and provides leadership for, compliance with federal and state laws and rules; exercises due diligence to prevent, detect, and report unlawful and/or unethical conduct.
- Ensures compliance within all external partners and vendors regulatory requirements.
- Provides independent review and evaluation to ensure that compliance issues/concerns within the organization are being appropriately evaluated, investigated, and resolved. Collaborates with other departments (e.g., Risk Management, Finance, Human Resources, etc.) to address compliance issues (e.g., investigation and resolution). Consults with the corporate attorney as needed to resolve difficult legal quality & regulatory issues.
- Identifies potential areas of vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues and provides general guidance on how to avoid or deal with similar situations in the future.
- Provides reports on a regular basis, and as directed or requested, to keep the Medication Safety Committee, the Executive Team, and the Board of Directors informed of the operation and progress of compliance efforts.
- Ensures proper reporting of violations or potential violations to duly authorized enforcement agencies as appropriate and/or needed.
- Lead change review process and oversee ownership related to implementation of new processes and technology.
- Serve as the Medvantx liaison to the Governance Committee of the Board.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Critical Skills
- Proven quality, compliance, and audit experience
- Curious about existing processes and confident enough to implement improvements
- Advanced computer skills in MS Office, accounting software and databases
- Ability to manipulate large amounts of data and to compile detailed reports
- Proven knowledge of auditing standards and procedures, laws, rules, and regulations
- High attention to detail and excellent analytical skills
- Sound independent judgement.
Qualifications
- Bachelor’s Degree or higher in Public Health, Human Services or related field required
- Advanced professional degree (i.e. PharmD, PhD., JD, etc.) preferred
- Two (2) years of recent leadership or progressive supervisory experience required
- Prior experience supervising and managing Quality Assurance/Improvement staff
- 5+ years of experience with pharmacy quality & regulatory
- 5+ years of experience within biopharma, pharmacy quality health system, or other pharmacy related background preferred.
- 3+ years progressively responsible experience conducting or managing one or more of the following: Investigations, CAPAs, FDA 21 CFR, audits, examinations, or program reviews.
- Extensive knowledge and ability to contribute in the areas of professional quality standards, data privacy, data integrity and data governance.
- Strong and effective verbal and written communication skills with the ability to customize the approach for a variety of audiences.
Physical Demands
- The physical demands of this position are in keeping with general office functions: sitting, using a computer, keyboard, telephone, etc.
- Reasonable accommodations can be made to enable employee to perform the essential job duties. (include in every job description)
- Preference for location in Louisville, KY or Sioux Falls, SD. Open to remote candidates on a case-by-case basis
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