Senior Manager, Clinical Quality Assurance

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

📋 Description

• Draft, review, and modify Clinical QA Standard Operating Procedures (SOPs) to evaluate consistency and adherence to regulatory requirements and internal standards.

• Participate in cross-functional team meetings, offering guidance to clinical operations personnel based on the interpretation of current regulations to promote best practices, including risk-based management.

• Collaborate closely with Clinical Operations to ensure the appropriate and comprehensive resolution of findings and non-compliance issues, quality investigations, etc., in a timely manner, including the approval of corrective action and preventative action (CAPA) plans as necessary.

• Conduct Quality Control (QC) reviews of clinical protocols, amendments, Informed Consent Forms, Clinical Study Reports, and other documents related to clinical trials.

• Assist and provide counsel in training QA and clinical staff as required for Good Clinical Practice (GCP).

• Identify potential systemic deficiencies and collaborate with relevant stakeholders to ensure prompt remediation.

• If necessary, escalate critical non-compliance issues and/or lack of urgency in remediation to senior management through the Quality Board.

• Execute program-specific root cause analysis of compliance issues and supply the appropriate metrics for tracking and trending in relation to overall QA reporting requirements for functional and senior management.

• Conduct and/or support internal audits (systems, processes, vendors, computer system validation).

• Coordinate with contract auditors during the scheduling process, facilitate kick-off meetings with auditors and internal teams, and assist in drafting audit plans, confirmation letters, and agendas, among other tasks.

• Recognize the need for and conduct or assist in external audits, which may include investigator sites, central IRBs, CROs, and clinical laboratories.

• Oversee the audit response process for Investigator Site and Contract Research Organization (CRO) audits/inspections, ensuring that actions taken to address findings are acceptable through the CAPA process.

• Aid in inspection readiness and regulatory inspections as required.

• Perform other duties and responsibilities as assigned.

⛳️ Requirements

• A minimum of 8 years of direct experience in GCP within the pharmaceutical or biotechnology sectors, along with a Bachelor's degree or equivalent qualification.

• Strong comprehension and application of GCP, GLP, and ICH requirements, particularly ICH E6R3.

• An organized, self-driven, and independent work ethic with the capability to initiate and complete assignments.

• Exceptional interpersonal abilities with knowledge of basic negotiation, influencing, and conflict management to ensure effective interactions within and across departments.

• The capacity to manage multiple project issues simultaneously while addressing time constraints, incomplete information, or unforeseen events.

• Extensive experience in product development, clinical operations, regulatory compliance, and GCP auditing.

• Willingness to travel up to 25% both domestically and internationally.

🏝️ Benefits

• Competitive salary along with an annual bonus.

• Comprehensive benefits package that includes medical, dental, vision insurance, a 401(k) retirement plan with company match, and more.

• Generous parental leave and family planning benefits.

• An exceptional culture with opportunities for personal and professional development.