Takeda Pharmaceuticals Senior Manager GCP Compliance in Topeka, Kansas
Lead compliance management efforts related to quality events and auditsfor clinical trial deliveryfunctions 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 coordinatecompliance 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
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
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 leadcompliance 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
Identifyand 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 preferred or commensurate with experience
6 + years' experience in the pharmaceutical in dustry 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 r e p orts 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
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.
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