Sr. Manager GRA Audits, Inspections and Compliance - Pipeline

Takeda Pharmaceutical Co.; Cambridge (MA); Sur place; USD 137 000 - 215 000; Plein temps

Résumé du poste

Takeda Pharmaceutical Co. in Cambridge, MA seeks a Senior Manager, GRA Audits, Inspections and Compliance to lead global regulatory audits and inspections coordination across Therapeutic areas, ensuring readiness and compliant practices.

The role partners with International Clinical Trial Regulatory Leads and Global Regulatory Leads to support audit readiness, provide live support, and manage post-audit follow-up while driving continuous improvement in regulatory processes and systems.

Qualifications

• Bachelor's degree in a science- or business-related field.
• At least 5 years in the pharmaceutical industry with 3+ years in clinical trial management, Regulatory Affairs, Quality Assurance or Compliance.
• Deep knowledge of global clinical trial regulations with cross-functional experience.
• Experience using Veeva platforms (RIM and Clinical).
• Strong communication skills to convey complex issues to diverse stakeholders.

Responsabilités

• Manage, coordinate and follow up on GCP audits and inspections globally.
• Partner with International Clinical Trial Regulatory Leads and Global Regulatory Leads on readiness.
• Act as liaison among GCP Compliance, GCP Excellence and Clinical Program Quality teams.
• Monitor and support regulatory compliance performance across therapeutic areas.
• Align GRA initiatives with stakeholders and develop regulatory processes and systems.
• Build relationships to implement global regulatory processes and drive automation where possible.
• Lead efforts to simplify and optimize business processes and platforms.

Connaissances

Cross-functional collaboration

Stakeholder communication

Risk management

Strategic thinking

Formation

Bachelor's degree in a science- or business-related field

Outils

Veeva RIM

Veeva Clinical

Description du poste

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.

Takeda Compensation and Benefits Summary

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.

Location

Cambridge, MA

U.S. Base Salary Range

$137,000.00 - $215,270.00

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.

EEO Statement

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.

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes