Quality Assurance Compliance Manager
Parexel International Corporation
USA - Any Region - Home Based
Home Based Role, US
The Compliance Manager (Principal Auditor) will have an in-depth understanding and knowledge of appropriate GxP compliance and other applicable regulations and laws, procedures and appropriate processes, which allows the individual to plan and conduct internal and external audits independently and to be able to mentor less experienced auditors. Auditors must be detail oriented, able to maintain a ‘big picture’ / overview on the project / business, exhibit a high degree of flexibility and initiative, demonstrate the ability to follow up on multiple tasks and projects, and possess the ability to handle confidential information diplomatically. In liaison with QA Management and staff, provide direction and coordination for project activities related to assigned areas. Provide advice on regulatory compliance.
The GCP Auditor should have a thorough understanding of Clinical Trials and Clinical Development, combined with an in-depth knowledge of ICH-GCP, other international GCP regulations / standards (e.g. as applicable: EU Clinical Trial Directive, US FDA Code of Federal Regulations) and, as required/ applicable, local relevant GCP guidance /regulations . The GCP auditor contributes to the execution of the GCP QA annual audit plan as assigned, may perform client contracted/billable audits, provides GCP consultancy to internal/external clients, where appropriate, and may contribute to the preparation/coordination/hosting/follow-up of client audits and/or regulatory inspections with a GCP focus, as assigned.Conduct risk-based GCP audits across all phases of Clinical Research including, but not limited to project related audits, system audits, supplier audits, pharmacovigilance (PV) auditsLocal, regional or global consultancy with regard to the implementation of GCP and PV requirements, and implementation of regulatory requirements in these areasProvide support and resources for regulatory inspections & sponsor auditsLiaise with external industry and regulatory inspectorate contacts and networks to determine best practice with regard to implementation of GCP and PV requirements across the PAREXEL CorporationKey Accountabilities:Facilitate sponsor audits / regulatory inspections, as assignedFosters a good working relationship with internal and external clientsWorking knowledge and expertise of PAREXEL policies, procedures, and guidelines, as well as applicable national and international regulations and requirements; able to apply them as neededPromotion of compliance within the companyPlan and conduct audits, including global and complex assignments, delivering a written reportProactively provide input to management on audit plans / strategyProactively recognize areas for process / procedural improvements, providing input to management and taking the initiative, as appropriateAbility to review and, if necessary, identify improvements that enhance the quality and clarity of audit reportsMaintain QA oversight and deliver QA consultancy for assigned countries/departmentsMaintain and / or develop records / documents related to assigned areasMentor and assist with training of less experienced auditorsTravel on assignment
QualificationsSkills:Ability to develop relationships with a culturally diverse group of key stakeholders within PAREXEL and the client’s businessExcellent interpersonal, verbal, and written communication skills, including ability to present at conferences, meetings, training sessionsExcellent analytical skillsAbility to manage multiple and varied tasks, and prioritize workloadExperience with Microsoft based applications, and ability to learn internal computer systems- Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamworkAccurate and detail orientedExcellent organizational skillsMotivated to work and perform consistently in a fast-paced environmentMinimum 5 years of GCP auditing experience of Early Phase and Late Phase clinical trials in the CRO and/ or Pharma industries requiredExperience hosting sponsor audits & regulatory inspections highly preferredDirect CRO or Pharma experience preferred in GCP auditingExperience at conducting: GCP Late Phase Investigator Site Audits Trial Master File Third Party Suppliers System/ Process Audits Pharmacovigilance AuditsGood knowledge of international regulatory requirements and industry guidelines governing global GCP (ICH, EMA, FDA, MHRA, PMDA) requiredKnowledge and experience of other GxPs (GLP, GMP, PV, GDP, GPP, etc.) preferredAbility to execute strategy and plansHigh degree of flexibility and ability to adjust to changing priorities and unforeseen events
Education:Bachelor’s degree in life science or equivalent experience gained by working in a relevant area (clinical research setting, laboratory, etc.).EEO DisclaimerParexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.