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VERO Biotech · 1 day ago

Director, Quality Compliance

Atlanta, GA

Full-time

Onsite

Director/Executive

8+ years exp

VERO Biotech is seeking a Director of Quality Compliance to manage the Investigation/CAPA program and ensure compliance with regulatory requirements. The role involves leading quality investigation teams, overseeing training programs, and participating in audits to maintain high-quality standards.

BiotechnologyHealth CareHealth DiagnosticsMedicalPharmaceutical

Responsibilities

Lead the Quality Investigation teams that complete NCR’s, Deviations, CAPAs, and Post-Market Investigations

Lead the Company-wide QMS Training program

Actively participate in the closure of investigations, root cause analyses, and implementation of corrective/preventive actions

Ensure timely completion of investigations in accordance with established company timelines

Maintain knowledge of current regulatory requirements pertaining to drug/device manufacturing and communicates requirements to associate staff members

Participate in routine internal audits of GMP systems

Monitor KPIs and perform data trending for quality metrics

Review and provide input for revisions to SOPs following assessments of systems and through conducting of investigations

Participate in continuous improvement objectives to assure compliance with regulations

Lead and mentor quality personnel, including promotion of quality culture and supporting quality objectives

Practices and promotes Good Manufacturing Practices

Other duties as assigned

Qualification

FDA regulations knowledgeQuality Management SystemsLeadership experienceAnalytical skillsCommunication skillsJudgementCreativeFlexibleOrganizational skillsInterpersonal skillsTeam player