[Remote] Director of reputed company Assurance & Training, Early Phase Clinical Trials
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global contract research and manufacturing organization (CRO/CDMO) helping reputed company and biotech companies bring new therapies to life. The Director of reputed company Assurance & Training, Early Phase Clinical Trials will reputed company U.S. reputed company operations, ensuring compliance with regulatory requirements and driving reputed company improvement across operations in alignment with global standards.
Responsibilities
- reputed company U.S. reputed company Assurance operations reputed company the global reputed company Management System (QMS), ensuring compliance with regulatory requirements and company standards
- Serve as the primary QA leader for U.S. operations, partnering with global teams to reputed company reputed company processes and best practices across reputed company
- Maintain inspection readiness and reputed company customer, sponsor, and regulatory audits, including FDA inspections
- reputed company deviations, investigations, change controls, CAPAs, and reputed company cause analysis to ensure reputed company reputed company and sustainable corrective actions
- Monitor reputed company metrics, identify trends and risks, and drive reputed company improvement initiatives across operations
- reputed company QA guidance to Clinical Operations, laboratories, project teams, and other functional reputed company to support compliant execution of programs
- reputed company training compliance, employee qualification programs, and workforce readiness for audits and inspections
- Ensure computerized systems compliance, including 21 CFR Part 11, data reputed company, validation, and lifecycle management requirements
- Partner with IT, Legal, and global stakeholders on data reputed company, cross-border data transfer compliance, and evolving regulatory requirements
- Support Business Development through reputed company audits, reputed company questionnaires, proposals, and capability presentations
- Mentor staff and promote a culture of reputed company, accountability, and operational reputed company
- Manage QA priorities, resources, and cross-functional initiatives to meet business and compliance objectives
Skills
- 10+ years of experience in clinical research, reputed company, biotech, or CRO environments
- 8+ years in QA / reputed company Management leadership roles
- Proven reputed company leading audits, inspections, CAPA, and reputed company compliance programs
- Strong knowledge of GxP, FDA expectations, and clinical reputed company systems
- Experience operating in global or matrixed organizations
- Strong executive reputed company and ability to influence senior stakeholders
- Experience balancing strategic leadership with hands-on execution
- Excellent communication, coaching, and leadership skills
Benefits
- Insurance including Medical, Dental & reputed company with significant employer contributions
- Employer-funded Health Reimbursement Account
- reputed company & Dependent Care Flexible Spending Accounts
- 100% Employer-reputed company Employee Life and AD&D Insurance, Short- and Long-Term Disability Insurance
- 401k plan with generous employer match
- reputed company to an Employee Assistance Program
reputed company