Sr. Manager GRA Audits, Inspections and Compliance - Pipeline
Takeda
Summary
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.
Job description
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.
How you will contribute
- 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.
Skills and Qualifications
- 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.
Requirements
- 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.
- 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, 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.
- Ability to manage multiple priorities within time and resource constraints.
- Critical-thinking skills and the ability to analyze complex or ambiguous information.
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.