Senior Manager, CQA Auditor

Job Title: Senior Manager, CQA Auditor

Location: Swiftwater, PA  

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

This position will be focused on assessing GCP Compliance in clinical related activities and supporting the Quality Management System to minimize risk.  Responsible for the preparation, 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.

Further responsibilities include coordination and management of inspections, the preparation of Transversal Quality Reviews (service provider / process), and support for project / study QRs as per need.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?​

Main Responsibilities:

• 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

• Leads the preparation, conduct, and reporting of assigned routine and non-routine GCP audits including Clinical Investigator Site, External Service Provider, and internal Process/System, to assess adherence to corporate standards, study requirements and compliance with applicable regulatory requirements. Non-routine audits may include Due Diligence or for-cause 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.

• During the audit, identifies potential issues and risks with impact on the Study, the Project or a specific process. Ensures adequate debrief and communication of these issues and risks.

• Escalates critical issues (i.e. events potentially requiring special risk management measures such as investigational panels) and supports at any subsequent meetings.

• Presents information logically and concisely, both verbally and in the writing of issued reports within the required timelines.  May provide advice and consultation on GCP and Quality issues during audit activities.

• Manages appropriateness of responses, the suitability of CAPA actions, and oversees the delivery of CAPAs actions arising from audits.  Responsible for the escalation of late CAPAs to the Management.

• Leads the preparation of Transversal Quality Reviews (service provider / project process), as assigned by CQA management.  May be asked to support project / study QRs in relation to audits conducted on the program.

• Leads the coordination and management of pre-inspection preparation visits, provides support to the inspection conduct, may directly host site level inspections, and oversee post regulatory inspection follow-up activities.  Ensures the establishment of proper responses with effective CAPAs and follows up on timely CAPA implementation in cooperation with the inspected sites, operational units or service providers.

• May represent the Sponsor during Sponsor level Regulatory Inspections, as requested by management.

• When required, oversees 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 participates in training on CQA activities and other topics related to GCP, regulations, and guidelines, etc.

• Participates in the development, revision, and implementation of Quality Documents, working methodologies, tools and systems related to audit activities.  Influences and persuades to bring about the process and technical improvements.  Support Pre/Post Acquisition activities, if applicable.

• Provides knowledge updates in areas pertaining to Audit and Inspection activities / GCP Regulations / Guidelines / Good Practices through review of literature and participation in relevant internal and external meetings/workshops/symposia.  Interprets and applies regulations/ policies to issues, when required.

• Supports the coaching of less experienced and / or newly hired GCP Quality Auditor(s).

COMPLEXITY & PROBLEM SOLVING

Major Challenges/Problems:

• Flexibility and willingness to accept frequent travels

Key Internal and External Relationships. 

• Internally, he/she will interact with all relevant functions part of Sanofi CSO Platform, Vaccine GBU and externally with the investigational sites, CROs, and co-development partners involved in the clinical research activities.

• The incumbent may also support investigators and sponsor/monitor inspectorate activities. As such, they may interact with representatives of Regulatory Agencies (FDA, MHRA, PMDA, NMPA, ANSM, EMA, etc.).

ACCOUNTABILITY

The position reports to the CQA Team Manager.

The position is considered fully remote with the need to attend onsite meetings occasionally as requested by CQ&CI/CQA Management. For full transparency, should the hired individual decide at some point to change positions within the company they would need to comply with the Global Working Policy in place at the time.

About You

• Bachelor's degree in a life / natural science or scientific discipline or equivalent with 5 years of experience
• Experience in Clinical Quality Assurance and/or in Clinical Trials such as Monitoring or Clinical Trial Management
• Extensive working knowledge of international regulations/Guidelines/Good Practices pertaining to the clinical domain
• Good working knowledge of standard computer office software
• Excellent communication skills (oral and written)

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 international regulatory knowledge

• Ability to propose pragmatic and innovative solutions to improve quality systems

• Appetite for and ability to deal rapidly with multiple and new computerized systems and digital tools used in clinical trials (vendors systems, new applications for patients…)

Formal Education And Experience Required:

• 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 

• Good business communication skills in English (orally / in writing)

Knowledge And Skills Desirable But Not Essential:

• Multi-lingual

Why Choose Us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.