Director, Quality & Regulatory

June 18

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Medvantx

Connecting patients, providers, and healthcare organizations to improve lives through service and technology.

201 - 500

Description

• Responsible for assuring the highest quality standards are met & maintaining a strong quality and regulatory adherent culture • Coordinate with various teams to ensure compliance processes for various functions • Lead the activities of the Medication Safety Committee and subcommittees • Review investigations, conduct CAPAs, and lead root cause analysis • Monitor medication safety benchmarks and proactively assess risks across the medication use & fulfillment process • Develop and maintain standard operating procedures in adherence with regulatory requirements • Create and monitor quality & regulatory KPIs to identify potential program risk

Requirements

• 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

Benefits

• 11 paid holidays • Generous Accrued Time Off increasing with years of service • Generous paid sick time • Annual day of service

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