Senior CQA Auditor (REMOTE)
Bridgewater, New Jersey
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Responsible for the initiation, conduct, and follow-up of audits as assigned by CQA Management. The audits and activities require proven ability to independently interact with all internal (e.g., Projects Teams, Operations…) and external (e.g., Vendors / CRO) operational staff involved in the audited clinical research activities. The responsibilities also include the mission of Clinical Project Quality Manager (CPQM) for the projects assigned by CQA Management.
Further responsibilities include the preparation of Quality Reviews for supported Project/Studies, coordination and management of inspection support, conduct of investigations of Scientific Misconduct and Serious GCP Non-Compliance and the handling of outsourced activities performed by external consultants on behalf of CQA, as required and assigned by CQA Management.
Independently manages and performs compliance audits of Contract Research Organizations (CRO).
Process Project-related and Clinical Investigator sites for Phase I to IV clinical trials. CRO / Process Project-related audits include external and/or internal processes such as IVRS, central labs, monitoring, data management, filing/archiving, medical writing, GCTM, study start up, DRS etc.
Lead both routine and complex directed audits.
During audits, the incumbent has direct access to subject individual data for records review and may have access to unblinded information/data. He/she is bound by professional secrecy and as such will not disclose any individual identity and/or individual medical information.
Represents CQA on various project/study team meetings. Acts as Clinical Project Quality Manager (CPQM) to provide quality and continuous improvement support at the study/project level. This includes responsibilities such as:
Follow-up on progress status of assigned project(s).
Establishment of regular contacts with operational teams.
Advice and consultation on GCP and Quality issues.
Identifying and analyzing potential issues with impact on quality.
Contribution to audit planning / programs and assistance in the monitoring of the implementation of those programs;
Participation in the analysis of results of audits for the assigned projects.
Conduct trend analysis for continuous improvement through Quality Reviews and Lessons Learned.
Proposing improvements and/or process changes.
May represent the sponsor during Regulatory Inspections, as requested by CQA management. This will include preparation, coordination and communication to management.
Ensures adequate inspection preparedness, provides support to the inspections, ensures the establishment of proper responses with effective CAPA, and follows up on timely implementation in cooperation with the inspected sites, operational units or CRO.
In liaison with management, manages cases of Scientific Misconduct and Serious GCP Non-Compliance. Practices and propagates a culture of early issue detection, timely escalation and resolution on an on-going basis. Escalates critical quality risks according to Sanofi policy (RQN).
When required, manages clinical auditing activities performed by external GCP QA auditors and assures CQA Management those activities are performed in a timely manner.
Assists in the design and participate in training on CQA activities and other topics related to GCP, regulations, and guidelines, etc.
Participates in the development, revision, and implementation of CQA Quality Documents, working methodologies, tools and systems.
Provides knowledge updates in areas pertaining to GCP Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/workshops/symposia.
Supports the coaching of less experienced and / or newly hired GCP Quality Auditor(s).
Bachelor degree in a life / medical / natural sciences or scientific discipline or equivalent.
Experience in Clinical Quality Assurance and/or in Clinical Trials such as Monitoring or Clinical Trial Management with good performance.
Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain.
Good working knowledge of standard computer office software such as Word, Email system (Outlook), PowerPoint and Excel.
Good business communication skills in English (orally/in writing).
Knowledge and Skills:
Rigor, diplomacy and integrity.
Good analytical abilities and attention to detail.
Ability to communicate clearly and effectively and to foster productive dialog on topics of advance complexity.
Ability to deal with multi-cultural environments
Capacity to work in team oriented environment.
Current regulatory knowledge.
Ability to propose pragmatic and innovative solutions to improve quality systems.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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