Senior Manager GCP Compliance

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Job Description
OBJECTIVES/PURPOSE

• Lead compliance management efforts related to quality events and audits for clinical trial delivery functions to ensure engagement of appropriate stakeholders, conduct of robust investigations and root cause analysis, appropriate CAPA plan development, and on time completion of CAPA/EC actions
• Manage and coordinate compliance assessments for clinical trial delivery functions including liaising with R&D QA and functional representatives, development of assessment plan, and timely completion and reporting
• Track and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery
  

Accountabilities
Compliance Management

• Manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting
• Support study teams and functional areas during internal audits by providing guidance on audit scope, facilitating audit requests, and managing the audit response process
• Serve as the GCP Compliance liaison for clinical trial functional areas and study teams and support study execution teams with compliance to clinical trial delivery procedures and assist with developing and implementing mitigation and escalation strategies
  

Compliance Assessments

• Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance
• Liaise with process owners and functional areas to develop and implement effective mitigation and escalation strategies for projects to address risks and issues
• Develop and lead compliance assessments to address GCP Quality Plan CAPAs/ECs and liaise with QA to ensure adherence to the plan
  

GCP Compliance Metrics and Reporting

• Partner with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities
• Identify and track KPIs, metrics and dashboards to track process quality and compliance
  

Other

• Responsible for training, coaching and mentoring supervised employees (direct and indirect reports) to create a culture that attracts, retains and develops innovative thinkers
• Act as role model for Takeda's values
  

Education, Behavioural Competencies And Skills

• Bachelor's degree preferred or commensurate with experience
• 6+ years' experience in the pharmaceutical industry and/or clinical research organization
• Solid knowledge of clinical trial management and/or GCP compliance processes
• Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders is required
• Comprehensive knowledge of regulatory requirements governing clinical trials and industry best practices
• Strong planning, execution, and communication skills
• Advanced knowledge of drug development and clinical trial processes, including related standards and documents.
• Good knowledge of clinical development training and process management, methods, and tools
• Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations
  

Additional Information

• This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.
• Base Salary Range: $130,200 to $186,000 . Employees may also be eligible for Short Term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
• The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
  

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.
Locations
Massachusetts - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
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