JobDescription
If you are a Jazzemployee please apply via the Internal Careersite
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is aglobal biopharmaceutical company whose purpose is to innovate totransform the lives of patients and their families. We arededicated to developing lifechanging medicines for people withserious diseases often with limited or no therapeutic options. Wehave a diverse portfolio of marketed medicines and novel productcandidates from early to latestage development in neuroscience andoncology. We actively explore new options for patients includingnovel compounds small molecules and biologics and throughcannabinoid science and innovative delivery technologies. Jazz isheadquartered in Dublin Ireland and has employees around the globeserving patients in nearly 75 countries. For more informationplease visit and follow @JazzPharma onTwitter.
BriefDescription:
This position willlead and participate in various types of GCP/GLP compliance auditsfor Jazz Pharmaceuticals development programs including but notlimited to clinical investigator sites service providers andinternal systems and processes globally. In addition this positionis responsible for supporting regulatory agencyinspections.
Essential JobFunctions:
Conduct/supportGCP/GLP compliance audits of clinical investigator sites serviceproviders and internal system/process audits in accordance with theannual audit plan to determine compliance status and identifycompliance risks
Prepare audit reports andcommunicate audit findings to audit stakeholders as well as RDQuality Management ensuring understanding ofobservations
Collaborate with clinicalcompliance leads to identify audit needs and follow up postauditactivities to ensure appropriate implementation of CAPA andmonitoring successful completion of action items
Assist in managing and training external auditors ensuringcompliance with Jazz Pharmaceuticals auditing standards andprocedures
Provide pertinent data to supportquality and compliance metrics and trending
Assist in the planning of clinical quality auditprograms
Develop and maintain study specificaudit plans (SSAPs) and audit certificates
Participate in strategic planning of organizational activities asrequired.
Support inspection management lead tomaintain Jazz RD inspection readiness at times
Participate in regulatory agency inspection activities pertinent toRD
Domestic and international travel isrequired
Qualifications
Minimum 5 years pharmaceutical or biotechnology industry experiencein performing audits and participating in regulatoryinspections
GCP audit experience is required GVPand GLP experience is valuable but not required
Knowledge/understanding of the perspectives of regulatoryagencies
Education
Bachelors Degree in Business or Life sciences is required advancedegree is preferred
Industry certification inQuality Assurance is preferred but notrequired.
Please use the below link for jobapplication and quickerresponse.
RemoteWork :
No