Sr. Manager GRA Audits, Inspections and Compliance - Pipeline

Takeda • Cambridge, MA

11d

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 partners with International Clinical Trial Regulatory Leads and Global Regulatory Leads, acts as a liaison among GCP Compliance, GCP Excellence, and Clinical Program Quality teams, and supports global regulatory compliance performance across therapeutic areas. It also aligns initiatives and implementation strategies with organizational stakeholders and helps simplify and optimize business processes and platforms, including through automation and harmonization.

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 skills and the ability to analyze complex or ambiguous information, assess its impact on products and processes, and communicate 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior