Senior Manager, GCP Quality Assurance

About the role

The Senior Manager, GCP Clinical Quality plays a critical role in ensuring compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP) regulations and guidelines. They partner with Clinical Development/Operations, Pharmacovigilance and Safety to identify and communicate clinical trial-related risks and opportunities for process improvement. Responsibilities include performing internal and external audits, supporting regulatory authority inspections, overseeing clinical compliance, and supporting the Quality Management System.

Responsibilities

• Perform internal and external audits as assigned to ensure compliance with GCP/GVP regulations and guidelines
• Provide GCP/GVP auditing activities, including audit preparation, execution, report preparation, and follow-up to any findings/observations, including corrective and preventive actions (CAPAs)
• Communicate audit results to internal stakeholders
• Support regulatory agency inspections and assist with GxP inspection readiness activities
• Oversee quality aspects related to clinical study start-up, execution, and close-out by providing leadership, guidance, and direction to staff consistent with GCP/GVP
• Avoid oversight of clinical compliance and quality within the context of cross-functional study teams
• Support Quality Management System (QMS) including, but not be limited to, the following activities: QA review/approval of deviations, CAPAs and change controls
• Draft, review, and approve policies, procedures and work instructions

Requirements

• A love of challenging, important work
• A minimum of 8 years of relevant experience in Quality Assurance or related role in a pharmaceutical, biotechnology, or related environment
• Develop and execute risk-based audit plans
• Develop and foster positive, collaborative relationships with internal staff as well as with external, third-party vendors
• Support regulatory agency inspections
• Write and review SOPs
• Experience using QMS (Veeva systems preferred)
• Knowledge and experience in Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) regulations

Preferred Candidate Profile

• Excellent verbal and written communication skills
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization, and time management skills including the ability to support and prioritize multiple projects

Pay Range

The base pay range for this position is expected to be $160,000 - $180,000 annually.