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Director Clinical Quality

AnovoRx

Director, Clinical Quality

The Director, Clinical Quality is responsible for leading accreditation and clinical quality initiatives within the Quality department, with a primary focus on accreditation readiness, audit preparedness, process improvement, CAPA support, and clinical quality metrics.

This role serves as a Quality department resource supporting accreditation management, process improvement, audit readiness, CAPAs, and quality oversight activities across the organization. The position partners cross-functionally with operational and support departments to help ensure accreditation standards, quality expectations, and regulatory or contractual requirements are effectively incorporated into workflows, documentation, monitoring activities, and quality initiatives.

Primary Duties and Responsibilities

  1. Lead and support accreditation readiness activities for URAC, ACHC, and other applicable accreditation standards.
  2. Coordinate accreditation evidence preparation, standards interpretation, gap assessments, and ongoing readiness activities.
  3. Partner with the Director, Quality Operations to support inspection and audit readiness initiatives.
  4. Support development, implementation, and monitoring of accreditation-related metrics and quality KPIs.
  5. Lead or support process improvement initiatives related to patient management, operational workflows, and accreditation findings.
  6. Collaborate cross-functionally to identify process gaps, compliance risks, and quality improvement opportunities.
  7. Support CAPA investigations, corrective actions, effectiveness monitoring, and process improvement activities related to accreditation or quality findings.
  8. Participate in therapy, program, or operational launches to ensure accreditation and quality requirements are incorporated into workflows and documentation.
  9. Assist with development, review, and revision of policies, SOPs, work instructions, forms, and quality documentation related to accreditation and quality oversight activities.
  10. Participate in Quality Committee, Clinical Oversight Committee, and other cross-functional meetings as needed.
  11. Support implementation and quality oversight of clinical software updates, assessments, protocols, and documentation workflows.
  12. Serve as a resource for interpretation of accreditation standards and quality expectations impacting operational workflows.
  13. Support preparation and presentation of accreditation and quality metrics for leadership meetings, committees, and audits.

Minimum Knowledge, Abilities, and Skills Required

Education and Licensing

  • Bachelor's degree in Pharmacy,
  • PharmD, preferred.
  • Active Pharmacist license in good standing

Experience

  • Minimum 10 years of pharmacy or healthcare experience
  • Minimum 5 years of accreditation, quality, audit, or compliance-related experience
  • Experience leading accreditation readiness, accreditation surveys, and ongoing accreditation management, including direct ownership of accreditation activities rather than support-only involvement
  • Experience with URAC, ACHC or similar accreditation standards
  • Experience with CAPA management, process improvement initiatives, and quality oversight activities
  • Experience developing, monitoring, and reporting quality metrics and accreditation-related KPIs
  • Experience interpreting accreditation standards and translating requirements into operational workflows, policies, and documentation
  • Experience participating in and leading audits, inspections, or accreditation surveys
  • Experience supporting implementation or oversight of operational or clinical workflow updates
  • Experience supporting organizational growth initiatives, launches, or expansion activities

Knowledge, Skills, and Abilities

  • Strong understanding of accreditation standards, quality systems, and audit readiness expectations
  • Ability to interpret standards and translate requirements into operational workflows and quality activities
  • Strong analytical and problem-solving skills
  • Ability to lead cross-functional discussions and drive follow-up actions
  • Strong organizational and project management skills
  • Ability to manage multiple priorities and deadlines simultaneously
  • Strong written and verbal communication skills
  • Ability to work independently and collaboratively across departments
  • Ability to identify process improvement opportunities and support implementation of corrective actions and quality initiatives
Vacancy posted 4 hours ago
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