Associate Director, GCP Compliance

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• Direct and drive the implementation of compliance management related to quality events and internal audits for 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

ACCOUNTABILITIES:

Compliance Management

• 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

Compliance Assessments

• 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, lead and 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

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 AND EXPERIENCE:

• Bachelor’s Degree or international equivalent required; Life Sciences preferred.
• 8 or more years' experience in the pharmaceutical industry and/or clinical research organization, including 6 or more years in compliance or clinical study management required.
• Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
• Experience in leading projects and coordinating collaboration with cross-functional teams.
• Strong strategic thinking, planning, execution, and communication skills.
• 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.

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.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.