Takeda Pharmaceuticals Associate Director GCP Compliance in Helena, Montana
At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.
Direct and drive theimplementation of compliance management related to quality events and internal auditsfor clinical trial delivery functions including the identification and development of applicable processes and tools
Establish and lead proactive risk-based compliance assessments for clinical trial delivery functions and ensure completion of robust CAPA/EC-related compliance assessments
Develop and report to leadership on key performance indicators and mitigation strategies for clinical trial delivery
Oversee and manage quality events/deviations including root cause analysis, CAPA development and implementation, effectiveness check tracking, and non-compliance reporting
Facilitate clinical trial delivery internal audits with study teams and functional areas including but not limited to:study team preparation, facilitating audit requests, managing audit responses and CAPA development and implementation.Partner with Quality Assurance to ensure appropriate audit scopes and clinical trial delivery participation.
Lead clinical trial functional areas and study teams on issues related to GCP compliance and liaise with study execution teams on compliance to clinical trial delivery procedures and developing effective mitigation and escalation strategies
Proactively identify process/therapeutic area/project risks and develop/lead assessments to assess compliance
Advise process owners and functional areas on the development and implementation of effective mitigation and escalation strategies for projects to address risks and issues
Develop, leadand oversee compliance assessments to address GCP Quality Plan, CAPAs/ECs and liaise with QA to ensure adherence to the plan
GCP Compliance Metrics and Reporting
Engage and build relationships with clinical trial delivery functions, R&D QA, and other stakeholders on performance metrics, analytics and reporting for GCP compliance activities
Identify, develop,and track KPIs, metrics and dashboards to track process quality and compliance
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 or international equivalent required ; Life Sciences preferred
8 + years' experience in the pharmaceutical industry and/or clinical research organization, including 6 + years in compliance or cl i nical study management
Experience in leading projects and coordinating collaboration with cross-functional teams
Strong strategic thinking, planning, execution, and communication skills
Global/international experience required , including ability to collaborate with colleagues and staff in other locations
Operational experience in clinical development with significant direct exposure to implementation of novel approaches in clinical development
Health care business acumen with a comprehensive understanding of the pharmaceutical industry
This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range: $143,500 to $205,000 . 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.
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.
Massachusetts - Virtual