| Location | Ridgefield, CT (Remote) |
Job ID: 37753992
Location: Remote – United States
Duration: 24 Months
Job Type: Contract
Work Arrangement: 100% Remote
Sigma Systems is seeking an experienced Site Quality and Compliance Lead for a 24-month remote contract opportunity supporting clinical development operations for a leading pharmaceutical organization.
This role focuses on clinical trial quality assurance, regulatory compliance, inspection readiness, CAPA management, and training development across Phase I–IV clinical trials and other clinical programs. The successful candidate will collaborate with clinical operations, quality assurance, regulatory affairs, legal, and medical teams to strengthen compliance, address quality findings, and promote continuous improvement.
The ideal candidate has a strong understanding of FDA regulations, ICH Good Clinical Practice (GCP), clinical operations, pharmaceutical quality systems, and clinical trial compliance. Experience developing training programs, supporting audits and inspections, managing corrective and preventive actions (CAPA), and analyzing quality metrics is highly desirable.
Implement clinical quality activities and support inspection readiness across clinical development operations.
Ensure clinical trial planning, preparation, conduct, and monitoring activities comply with applicable FDA regulations, ICH-GCP guidelines, company SOPs, and local working instructions.
Develop and deliver just-in-time training programs for U.S. Clinical Development Operations (CDO) teams.
Support training curriculum development by evaluating course materials, learning methods, and role-specific training needs.
Collaborate with clinical operations, Quality Medicine, Legal, Medical Affairs, Regulatory Affairs, and other cross-functional partners to address quality and compliance matters.
Support responses to sponsor inspection findings and internal audit observations, including corrective and preventive action planning.
Review clinical operations processes and identify opportunities to improve quality, compliance, and inspection readiness.
Serve as a primary point of contact for U.S. CDO non-compliance issues, coordinating triage, escalation, and resolution with quality partners.
Participate in non-compliance meetings and support trial teams in developing, implementing, and monitoring CAPA plans.
Track and report quality metrics, identify adverse quality trends, assess compliance risks, and recommend appropriate mitigation strategies.
Support onboarding programs, process improvement initiatives, and training interventions to address quality or performance gaps.
Communicate lessons learned, compliance trends, and quality improvement recommendations across clinical operations teams.
Contribute to global quality initiatives and cross-functional programs that strengthen clinical trial compliance and operational effectiveness.
Maintain high ethical and professional standards while ensuring adherence to applicable regulatory requirements and company policies.
Bachelor's degree required; a degree in life sciences or a related scientific discipline is highly preferred.
Current knowledge of pharmaceutical development processes and clinical trial operations.
Understanding of applicable FDA regulations, ICH-GCP guidelines, and clinical research compliance requirements.
Ability to learn and apply company SOPs, local working instructions, and role-specific training requirements.
Strong understanding of clinical quality management, inspection readiness, and regulatory compliance principles.
Excellent written and verbal communication skills, including the ability to communicate quality requirements to cross-functional teams.
Strong project and program management skills, with the ability to coordinate multiple initiatives and meet deadlines.
Demonstrated organizational skills, attention to detail, accountability, and sound judgment.
Ability to identify compliance risks, evaluate quality trends, and support effective problem resolution.
Strong collaboration and stakeholder management skills in a cross-functional environment.
Ability to work independently in a remote setting while coordinating effectively with distributed teams.
Experience in clinical quality assurance, clinical operations quality, or pharmaceutical compliance.
Experience supporting Phase I–IV clinical trials, registries, expanded access programs, or survey trials.
Previous involvement in sponsor inspections, regulatory inspections, internal audits, or inspection readiness activities.
Experience developing and delivering clinical operations training programs or GCP compliance training.
Hands-on experience supporting deviations, non-compliance investigations, CAPA plans, and quality issue resolution.
Experience preparing quality metrics, trend reports, risk assessments, and compliance dashboards.
Familiarity with pharmaceutical quality systems, process improvement initiatives, and global clinical development organizations.
Experience working with cross-functional clinical operations, Quality Assurance, Regulatory Affairs, Medical Affairs, and Legal teams.
Clinical Quality Assurance and Compliance
Good Clinical Practice (GCP)
FDA and ICH Regulatory Requirements
Clinical Trial Inspection Readiness
Corrective and Preventive Action (CAPA)
Audit and Inspection Support
Clinical Operations Quality Management
Quality Metrics and Trend Analysis
Risk Assessment and Mitigation
Clinical Compliance Training and Curriculum Development
Project and Program Management
SOP and Process Improvement
Cross-Functional Collaboration
Stakeholder Communication
Continuous Improvement and Quality Excellence
Position: Site Quality and Compliance Lead
Job ID: 37753992
Duration: 24 months
Location: Remote within the United States
Employment Type: Contract
Education: Bachelor's degree required; life sciences preferred