Sr. Manager GRA Audits, Inspections and Compliance - Pipeline
About The Position
The Senior Manager, GRA Audits, Inspections and Compliance (GRAIC) - Pipeline provides expertise and support for the global management, coordination and follow-up of GCP audits and inspections related to Regulatory Affairs processes. The role helps ensure inspection readiness, provides live support during audits and inspections, manages post-audit and post-inspection follow-up, and drives continuous improvement across Global Regulatory Affairs. The position manages and coordinates global GCP audits and inspections related to Regulatory Affairs, partners with International Clinical Trial Regulatory Leads and Global Regulatory Leads, and serves as a liaison among GCP Compliance, GCP Excellence and Clinical Program Quality teams. It also supports global regulatory compliance performance, aligns initiatives with stakeholders, develops global regulatory processes and systems, and leads efforts to simplify and optimize business processes and platforms, including automation and harmonization opportunities.
Requirements
- Bachelor's degree in a science- or business-related field.
- At least 5 years of experience in the pharmaceutical industry, including at least 3 years in clinical trial management, Regulatory Affairs, Quality Assurance and/or Compliance.
- Deep knowledge of global regulations related to clinical trials across major markets.
- Practical experience working cross-functionally and across regions in multicultural, matrixed organizations.
- Experience using the Veeva platform, including Veeva RIM and Veeva Clinical.
- Clear and effective verbal and written communication skills, including the ability to synthesize and communicate complex issues to diverse internal and external stakeholders.
- Ability to proactively identify and anticipate risks of non-compliance in a complex environment.
- Ability to manage conflict tactfully and diplomatically while seeking effective solutions for all parties.
- Ability to manage multiple priorities within time and resource constraints.
- Critical-thinking and analytical skills, including assessing complex or ambiguous information and its impact on products and processes, and communicating findings effectively.
Responsibilities
- Manage, coordinate and follow up on global GCP audits and inspections related to Regulatory Affairs processes, helping ensure readiness and compliance.
- Partner with International Clinical Trial Regulatory Leads and Global Regulatory Leads to support audit and inspection readiness.
- Act as a liaison among GCP Compliance, GCP Excellence and Clinical Program Quality teams.
- Monitor and support global regulatory compliance performance for Global Regulatory Leads across therapeutic areas, including Neuroscience, Oncology, Gastrointestinal, MPD and International Clinical Trial Regulatory Leads.
- Align Global Regulatory Affairs initiatives and implementation strategies with relevant organizational stakeholders.
- Build collaborative relationships with Global Regulatory Leads and International Clinical Trial Regulatory Leads to develop and implement global regulatory processes and systems.
- Lead and contribute to efforts to simplify and optimize business processes and platforms, including opportunities to automate and harmonize processes.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
