Director, GCP Inspection Strategy - REMOTE

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Director, GCP Inspection Strategy -REMOTE

OBJECTIVES/PURPOSE:

• Lead/drive development and implementation of inspection readiness strategy and framework focused on study execution team preparedness, partnering with cross functional teams to ensure inspection-ready delivery of clinical programs in compliance with internal process and external regulations
• Oversee execution of all activities related to Inspection Readiness, including strategy, study team leadership and management and close collaboration with both QA and clinical trial delivery functional leadership
• Oversee clinical trial delivery regulatory inspections, in conjunction with QA. Ensure accurate and appropriate documentation is provided during inspections, working with functional area teams to define strategy and deliverables.

ACCOUNTABILITIES:

Inspection Strategy, Readiness & Execution

• Plan and develop inspection readiness framework focused on clinical study team preparedness, partnering with cross functional leadership to establish inspection “norms” and processes across therapeutic areas
• Oversee implementation and execution of all activities related to inspection readiness framework, including team preparation, inspection tools, storyboards, processes and interactions across Quality Assurance
• Lead Inspection Readiness and Strategy support forteams prior to anticipated global and regional regulatory inspections (BIMO, pre-approval, GCP inspections, etc.)
• Lead and facilitate, in conjunction with Quality Assurance, formal inspection activities including team logistics, document requests, clarifications, inspection responses and CAPAs
• Serve as Clinical Trial Delivery SME for inspections and audits
• In conjunction with QA, strategize and provide functional area insight on internal audits (process, vendor, etc) to maximize clinical trial quality audits for proactive inspection readiness
• Establish and implement process, in alignment with QA, to support study site inspection readiness to ensure documentation and records at sites (e.g. high-enrollment centers) are ready for inspection by regulatory authorities

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 or international equivalent required, Life Sciences preferred
• 10+ years experience in the pharmaceutical industry and/or clinical research organization, including 6+ years in clinical study management, including at least 6 years of line management experience
• Experience in people leadership, managing global teams 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

Base Salary Range: $160-229K. 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.

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