Sr. Manager GRA Audits, Inspections and Compliance - Pipeline

About the role

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. This 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.

• Manage, coordinate and follow up on GCP audits and inspections related to Regulatory Affairs processes globally, helping ensure readiness and compliance.
• Partner closely 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 stakeholders across the organization.
• 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 that simplify and optimize business processes and platforms, including opportunities to automate and harmonize processes.

• Bachelor's degree in a science- or business-related field.
• Minimum of 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, with 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 communication skills, with the ability to synthesize and communicate complex issues to diverse internal and external stakeholders, both verbally and in writing.
• 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.

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

Cambridge, MA

$ - $

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Employee

Regular

Full time

Yes