Associate Director Clinical Quality Assurance

Location: Boston, Hybrid (3x/week onsite)

Overview

A leading global pharmaceutical organization is seeking a Senior Clinical Quality Assurance Manager to support and oversee GCP compliance across clinical development programs. This individual will play a critical role in ensuring quality standards, inspection readiness, and regulatory compliance across a diverse and innovative R&D portfolio.

The company, with a $30B+ market cap and ~$6B in annual revenue, operates with the agility of a biotech while leveraging the resources of an established organization.

Why This Opportunity?

• High-impact role supporting global clinical programs and innovation pipeline
• Strong visibility across cross-functional leadership and clinical teams
• Opportunity to shape and influence quality strategy and inspection readiness globally
• Work within a collaborative, science-driven environment

Responsibilities

• Support the development and execution of the R&D Quality Assurance strategy across clinical development programs
• Define and implement quality objectives aligned with business priorities and budget considerations
• Lead and support GCP audit programs, including internal audits and vendor/service provider qualifications
• Conduct internal and external audits (systems, processes, and documentation) to ensure compliance
• Partner with cross-functional teams as the QA representative on clinical study teams, providing proactive quality guidance
• Evaluate outsourced activities and ensure compliance with vendor governance and GCP requirements
• Contribute to the enhancement of the Clinical Quality Management System (QMS), including SOPs, policies, and procedures
• Support regulatory intelligence activities to ensure alignment with evolving global GCP requirements
• Deliver GCP training and promote quality culture across R&D teams
• Ensure inspection readiness and lead/coordinate global regulatory inspections
• Analyze quality trends and provide insights to mitigate risks to clinical program outcomes
• Represent QA at industry forums and contribute to external visibility and thought leadership

Requirements

• 7-10+ years of experience in Clinical R&D and Quality Assurance
• Proven experience with GCP audits, inspections, and QMS improvements
• Experience supporting clinical development programs in regulated environments
• Familiarity with QA and clinical systems such as TrackWise, Documentum, Trial Interactive, etc. is desired
• Knowledge of computer system validation (e.g., GAMP, 21 CFR Part 11) is preferred, but not required

Pay

Base Salary Range: $150,000 – $180,000. In addition to base salary, this position is eligible for a target annual performance bonus of 20% and a comprehensive benefits package.