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Director, Research & Clinical Development Quality Assurance

Company: HealthCare Traveler Jobs
Location: Somerville
Posted on: September 17, 2020

Job Description:

Director, Research & Clinical Development, Quality Assurance Company: Sarepta Therapeutics

Location: Somerville

Posted on: September 9, 2020

Job Description:

The Position:The Director, Research &Clinical DevelopmentQuality Assurance will be responsible for the management of theSarepta internal and external audit program, risk based audit plandevelopment, and the conduct of GLP/GCP/GVP audits. The Directorwill also be responsible for vendor risk assessment and vendorqualification, GxP audit consultation managment, and thedevelopment of performance, quality and risk metrics. This positionwill participate in inspection readiness activities and audits, asappropriate. This position will have direct reports and will reportto the Senior Director, Research & Clinical Development QualityAssurance. Primary position responsibilities include:Develop andmaintain the internal and external GLC/GCP/GVP annual audit planfor sites and vendors and update the audit plan as needed based onidentified risks and trial prioritiesEnsure that audit results areformally and consistently recorded, conducted, reported and thatappropriate corrective/preventive actions have been requested anddocumented effectivelyParticipate in the risk assessment of all newand current vendors/CRO partners and conduct or coordinate vendorqualification audits/assessments as neededEnsure compliance ofquality management system with applicable regulations, qualityguidelines and standardsAssist in the development and maintenanceof GxP audit management documentation including policies, SOPs andguidelines.Manage and conduct trend analysis of assigned CQAmetrics including GCP Study Quality, IR activities, and auditobservations and communicate metrics and compliance risks to QAManagement.Collaborate with Clinical Trial Team members to assessongoing audit needs and provide GxP guidance to functional teams,and execute directed audits, where required.Participate ininspection readiness and preparedness activities (i.e., sponsormonitor, sites, etc.) and provide guidance and support for all GxPinspection activitiesSupport internal and external regulatoryinspections and Inspection Readiness activitiesCoordinate andmanage Audit Consultants as appropriateRequirements:Bachelor'sdegree in the Life Sciences with 10+ years in pharmaceutical orbiotech drug development. Advanced degree preferred.Minimum 10years of experience in Clinical QA, including both external andinternal auditing.Previous management experiencerequired.Demonstrated experience working with clinical trialteams.Extensive experience with Global Clinical trial conduct,knowledge and understanding of ICH E6 (R2) GCP Guideline, FDARegulations and EU Requirements.Previous experience facilitatingand/or supporting Regulatory Authority Inspections.Directexperience in development and oversight of Quality ManagementSystems.Excellent interpersonal skills, personal integrity,professional manner and ability to gain respect and develop goodworking relationship with cross functional personnel at alllevels.Candidates must be authorized to work in the U.S.SareptaTherapeutics offers a competitive compensation and benefitpackage.Sarepta Therapeutics is an Equal Opportunity/AffirmativeAction employer and participates in e-Verify.

Keywords: Sarepta Therapeutics, Waltham , Director, Research & Clinical Development, Quality Assurance, Healthcare , Somerville, Massachusetts

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Keywords: HealthCare Traveler Jobs, Somerville , Director, Research & Clinical Development Quality Assurance, Other , Somerville, Massachusetts

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