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Associate Director

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: CSTE

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Council of State and Territorial Epidemiologists Using the powerof epidemiology to improve the public's health

Council of State and Territorial Epidemiologists AssociateDirector, Clinical Quality Assurance

Associate Director, Clinical Quality Assurance The AssociateDirector, Research & Clinical Development QA, Quality Operationswill be responsible for the oversight and support of the SareptaClinical Development portfolio. The qualified candidate will serveas a Subject Matter Expert to ensure that activities performed byMedical/Clinical/Pharmacovigilance departments are in compliancewith regulatory requirements related to GLP, GCP, and GVP. TheAssociate Director will be responsible for the program level QAoversight of clinical studies, vendor and internal process andprocedures. This position will provide Clinical Trial Team supportand promote collaboration to ensure all clinical trial activitiesand outcomes are compliant with GLP/GCP/GVP guidelines, andapplicable international standards. This role will promoteinspection preparation and readiness within Clinical Operations andfacilitate regulatory authority inspections. This position reportsto the Director, Research & Clinical Development Quality Assurance(R&CD QA).

Primary Responsibilities Include:

Proactively provides GXP QA support and guidance to ClinicalOperations based on analysis and interpretation of GXP regulationsto assure best Clinical/QA practices

Assist Clinical Operations in the development of CAPA plans andinvestigations in response to audits and inspections review

Represent R&CD QA on the clinical and non-clinical teams andprovide compliance advice and guidance

Provide surveillance of upcoming regulations and regulatoryauthority interpretations, share with R&CD QA staff andleadership to inform R&CD QA program development and directcompliance initiatives

Manage the resolution of compliance issues or delegate to otherqualified persons identified at clinical and non-clinical vendorsand clinical sites and provide assessment of the impact of anydeficiencies

Participate in the implementation of GXP compliant proceduresand operations to ensure a robust quality management system forboth the conduct of clinical studies

Develop and implement process improvements to internal programsas indicated by issue management, audit observations, newregulations, guidance documents, and industry standards

Assist departments, functional groups and subcontractors asnecessary with the development, review and implementation ofSOPs

Act as primary point of contact for customers regarding R&CDQA, providing comprehensive information on processes and qualitymeasures

Provides training sessions on topics related to GCP quality andglobal regulations

Support in Inspection Preparation and Inspection ReadinessActivities

Perform other related duties and special projects as needed

Education and Skills Requirements:

Bachelor’s degree in the Life Sciences with 10+ years inpharmaceutical or biotech drug development. Advanced degreepreferred

7-10 years of experience in Clinical QA, including both externaland internal auditing

Demonstrated experience working with clinical trial teams

Extensive experience with Global Clinical trial conduct,knowledge and understanding of ICH E6 (R2) GCP Guideline, FDARegulations and EU Requirements

Previous experience supporting Regulatory AuthorityInspections

Experience in development and oversight of Quality ManagementSystems

Excellent interpersonal skills, personal integrity, professionalmanner and ability to gain respect and develop good workingrelationship with cross functional personnel at all levels

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation andbenefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Actionemployer and participates in e-Verify.

Job Information

Job ID: 54073442

Location:

Cambridge, Massachusetts, United States

Position Title: Associate Director, Clinical QualityAssurance

Sarepta Therapeutics, headquartered in Cambridge, Massachusetts,is a commercial-stage biopharmaceutical company focused on thediscovery and development of unique RNA-targeted therapeutics forthe treatment of rare neuromuscular diseases. The Company isprimarily focused on rapidly advancing the development of itspotentially disease-modifying DMD drug candidates. For moreinformation, please visit us at www.sarepta.com.

2635 Century Parkway NE, Suite 700 Atlanta, Georgia 30345 (770)458-3811

Keywords: CSTE, Cambridge , Associate Director, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Associate Director, Other , Cambridge, Massachusetts

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