This individual will also be required to mentor and train Issue Leads to ensure the individuals reviewing the submitted issues are qualified to assess and categorize the submitted Quality Events.
Audit and Inspection Coordination
This individual may be assigned additional focus areas in audit coordination or inspection coordination, including inspection responsibilities around:
Directing asset/study team colleagues within CD&O/Clinical to ensure successful inspection and audit outcomes
Communicating audit and inspection progress and needs to CS&O/Clinical stakeholders
Serving as the point of contact for Regulatory Quality Assurance related to audit and inspection CAPA management
Quality Compliance Assessment
Plan, lead and report out on Quality and Compliance Assessments related to CD&O processes
Root Cause Analysis
This individual will also be required to apply a root cause methodology and/or due diligence approach to assigned QEs. This individual may either lead QE cases from start to finish
Job Requirements :
BS - 10+ years or equivalent
MS/MBA - 9+ years or equivalent
Previous Experience:
Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
Regulatory inspection experience
Process and system management experience
Detailed knowledge of clinical trial processes and relationships required
Knowledge of GCP requirements and applicable SOPs and regulations
Project management, administrative, and technical capabilities are required, as well as effective verbal and written communication skills
Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred
Benefits
Health insurance
Additional Information
When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
Parexel FSP is looking for multiple Senior Issue Leads to join our team. The candidates can be based anywhere in Argentina, Mexico or Brazil !
The Senior Issue Lead will be accountable for
Quality Events: managing confirmed Major/Critical Quality Event (QE) cases through the investigation process including root cause analysis. The Senior Issue Lead will ensure the investigations are conducted thoroughly, within required timelines and to compliance requirements including ensuring the adequacy of root cause analysis and appropriateness of communication regarding the case. The Senior Issue Management Lead will direct the QE team in proposing appropriate Corrective and Preventative Actions and that completion of all those are evidenced in documentation as required. The Senior Issue Lead will be assigned to and manage Critical and other complex cases and especially those that require presentation to senior leaders as part of the Quality Review Team (QRT)
Audits and Inspection Coordination: Drive GCP quality in withstanding regulatory scrutiny, operational data and documentation; major areas of focus will include a udit coordination for GCP related process and preferred CRO vendor audits and CAPA management
Directing Inspection readiness and providing inspection support for GCP sponsor inspection activities
Parexel · Argentina