Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations.
Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends.
Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies.
Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function.
Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues.
Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions.
Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures.
Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles.
Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

Requirements

Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required. Advanced degree preferred.
Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance.
Strong applied knowledge of global GxP regulations applicable to clinical development, including:
Good Clinical Practice (GCP)
Good Pharmacovigilance Practice (GVP)
Good Laboratory Practice (GLP)
GMP experience is not required for this role
Experience with the following is desired:
Quality management and oversight of clinical trials
Quality event and CAPA management
Regulatory inspection readiness and inspection support
Risk-based quality management approaches
Planning of clinical audits (including sites, internal audits)
Developing metrics and reviewing issues for quality signals and trends
SOP governance through controlled document reviews
Training matrix or training governance activities
Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.

Benefits

Health insurance
401(k) matching
Flexible work hours
Paid time off
Remote work options

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical quality oversightquality event managementCAPA managementregulatory inspection readinessrisk-based quality managementclinical audits planningSOP governancetraining governanceroot cause analysisquality signal analysis

Soft Skills

leadershipcommunicationproactive guidancecollaborationproblem-solvinganalytical thinkingorganizational skillsattention to detailprocess improvementstakeholder management

Certifications

RQAPCQACCRCRAC