Manager, GCP Compliance and Inspection Strategy - REMOTE

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REMOTE OPPORTUNITY

OBJECTIVES/PURPOSE:

• Manage study execution teams in GCP inspection readiness and inspection activities
• Be the clinical trial delivery compliance function on Quality led inspection preparations, internal audits, quality events, and regulatory inspections
• Ensure clinical trial delivery compliance by managing quality event/deviation process, CAPA development, and effectiveness check tracking
• Champion change for clinical trial delivery projects

ACCOUNTABILITIES:

Inspection/ Audits Capability

• Manage study execution teams in regulatory inspection readiness activities focused on clinical trial delivery process and functional area compliance in partnership with Quality
• Coordinate storyboard development with the team, focusing on high risk and high impact areas as part of inspection readiness activities.
• Create documentation, such as plans, timelines, progress reports, measuring compliance and quality communicating actions to team members
• Be the functional area compliance contact for Quality led internal audits and regulatory inspections
• Active participation on Quality Inspection meetings, ensuring timely completion of deliverables following agreed upon timelines
• Work with subject matter experts and Quality in preparation for audit and inspection implementation and follow-up

Compliance and Deviation Management

• Manage quality investigations with teams to determine root cause and overall impact
• Support study execution teams on compliance to clinical trial delivery SOPs; manage non-compliance
• Identify and highlight risks within project(s) and escalate. Implement mitigation and escalation strategies for projects to address risks
• Manage CAPA, EC tracking for supported
• Manage non-compliance including deviation determination, documentation, collaborating with Quality

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• 4+ years clinical research experience in pharmaceutical or biotechnology field
• Solid knowledge of clinical trial management and GCP compliance processes
• Experience with negotiations and collaborative team building with non- direct reports and other partners is required
• Solid knowledge of regulatory requirements governing clinical trials and industry best practices
• Minimum Bachelor's degree, MS or equivalent in scientific field
• Solid knowledge of drug development and clinical trial processes, including related standards and documents.

Base Salary Range: $130-150K, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. 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.

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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