Senior Manager, GCP Quality Assurance

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Offer strategic oversight and consultation for GCP quality to study teams throughout all stages of clinical trial execution.

• Conduct and/or oversee GCP audits of CROs, vendors, investigator sites, Trial Master Files, and internal R&D processes.

• Evaluate root cause analyses and the effectiveness of CAPA, ensuring timely resolution of audit findings and quality concerns.

• Manage clinical quality events, deviations, investigations, and CAPAs, including risk-based assessment, remediation, and trend analysis.

• Aid in the development, maintenance, and ongoing enhancement of the Clinical Quality Management System, encompassing quality policies, SOPs, and training initiatives.

• Facilitate inspection readiness efforts and deliver quality support during regulatory inspections of Aura and participating investigator sites.

• Participate in regular internal and external clinical study team meetings and ad hoc discussions.

• Perform risk-based quality evaluations of clinical trial documentation.

• Contribute to departmental metrics analysis and reporting.

⛳️ Requirements

• A bachelor's degree in life sciences, nursing, pharmacy, or a related discipline; equivalent professional experience will be taken into account.

• An advanced degree is advantageous.

• 6-10+ years of experience in clinical research, pharmaceuticals, or biotechnology.

• At least 5 years of experience in a Clinical Quality Assurance or Clinical Compliance position.

• Proven experience conducting audits of clinical sites and vendors that provide clinical services.

• Strong background in global clinical trial operations.

• Comprehensive knowledge of applicable ICH Guidelines, FDA Regulations, as well as MHRA, EU, and Health Canada requirements.

• Exceptional interpersonal abilities, personal integrity, professionalism, and the capacity to earn respect and foster productive relationships with cross-functional teams at all levels.

• Outstanding written and verbal communication skills.

• Willingness and ability to travel domestically and internationally for audits, as necessary.

• Previous experience assisting with Regulatory Authority Inspections is preferred.

• Experience in GLP and/or GVP is a plus.

🏝️ Benefits

• Comprehensive health insurance with FULL premium coverage.

• 401K plan with company matching.

• Employee Stock Purchase Program (ESPP).

• Competitive paid time off (PTO).

• Company-funded short & long-term disability insurance and life insurance.