Associate Director Clinical Quality Assurance
Mix Talent
Boston, MA
Quality Assurance / Control
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.
Why This Opportunity?
- 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.
- 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
- 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
- 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
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.
Job Identifier: #9319
About the company
Company website•Biotechnology Research and Pharmaceutical Manufacturing
Mix Talent was built to support the near-term goals and long-term success of pharma, biotech, med device, and gene therapy organizations. We recognize the power of your company culture, and we specialize in identifying, recruiting, assessing, selecting, and developing talent that fits and fortifies that culture. As our name demonstrates, we believe it’s essential to find that right mix of skills, experience, personality, and personal motivation to ensure long-term success. And to do that, you need to do it differently. Our unique mix of knowledge, technology, and instinct has helped clients go beyond just hiring headcount to truly creating dynamic organizations. The secret’s in the mix.