Associate Director, Quality Assurance Auditing

Science 37•Morrisville, NC

About The Position

Science 37 accelerates clinical research by expanding patient access to trials, leading to faster approvals and better health outcomes for all. Our solutions empower life sciences companies to reach diverse populations beyond traditional means of conducting clinical research POSITION OVERVIEW The Associate Director, Quality Assurance Auditing will represent Science 37 Quality and Compliance’s key interests with regard to quality management including, but not limited to: conducting and reporting GxP audits, ongoing quality document development and management, investigation and resolution of quality concerns, and KPI development and monitoring, as applicable.

Requirements

Bachelor’s Degree in science, engineering, or another related field required or 6+ years of experience in quality or compliance in clinical research, biotechnology, or other GxP or regulated environment, or requisite combination of education, training and experience
Knowledge of cGxP regulations, CSV process and industry best practices
Excellent organizational and project management skills; able to track and manage complex processes from start to finish
Analytical and problem-solving skills, with ability to operate at all organization levels
Strong and effective verbal and written communication skills with the ability to customize approach for a variety of audiences
A track record of successful cross-functional leadership and delivery through collaboration and effective relationships
Extraordinary focus on details, analysis and results including ability to work on complex issues with multiple dependencies and stakeholders to drive consensus
Ability to tactically implement a strategic vision
Ability to communicate in English (both verbal and written)
Primarily domestic travel required up to 20-40%; international travel potential <10%

Responsibilities

Prepares, conducts, reports on and supports conclusion of audits and associated observations in all of the following categories: GCP, GLP, GMP and CSV
In partnership with operational functions and other stakeholders, assesses the need for quality-related KPI definition, implementation and monitoring
Liaises with the head of Solutions Consulting and or their designee(s) on topics of mutual interest including, but not limited to: results of periodic vendor assessments, vendor quality metrics, and vendor quality or performance concerns
Oversees Sponsor Quality Management Agreements under which Science 37 is the vendor; ensures the fulfillment of the necessary requirements such as notifications, KPIs and governance-related activities
Lead and manage regulatory inspections and audits (e.g., FDA, sponsor, internal), including preparation, conduct, response development, and follow-up on corrective and preventive actions (CAPAs).
Maintain a state of ongoing audit readiness by establishing and monitoring quality metrics, inspection readiness plans, and proactive risk identification.
Serve as a primary Quality point of contact for clients and sponsors, supporting audits, responding to quality inquiries, and fostering strong, transparent partnerships
Own the development, review, approval, and lifecycle management of SOPs, work instructions, templates, and quality frameworks to ensure alignment with regulatory requirements and business needs.
Oversee compliance tracking and management activities, including deviation management, CAPAs, change control, and quality issue trending and reporting.
Partner cross-functionally to embed quality into day-to-day execution.
Provide line management and mentorship for Quality team members, including performance management, professional development, and workforce planning.
Promote a culture of quality, accountability, and continuous improvement across the organization
Remains abreast of current, evolving and new regulations, guidance, and industry best practice