Director, Clinical Quality Assurance

Role Summary

The Director, Clinical Quality Assurance leads GCP compliance and quality oversight for clinical programs and commercial products. This role is responsible for developing and implementing risk-based strategies; managing audits, inspections, and vendor oversight; and ensuring global regulatory compliance. This role partners cross-functionally to drive continuous improvement, inspection readiness, and sponsor oversight, while proactively identifying and mitigating quality risks. As a subject matter expert, this role establishes program support to uphold industry best practices and regulatory requirements.

Responsibilities

• Inform and contribute to audit planning and strategy
• Perform and/or coordinate clinical site and vendor audits
• Oversee deviations, quality issues (QIs), CAPAs, effectiveness checks, root cause analyses, and associated KPIs
• Advise internal stakeholders and external partners on GCP compliance matters and identify emerging non-compliance trends
• Support inspection readiness activities and co-host regulatory inspections
• Develop and deliver GCP-related training; contribute to the creation, revision, and maintenance of policies, SOPs, and work instructions in alignment with global regulatory requirements
• Conduct and/or manage the qualification and oversight of service providers
• Ensure service providers adhere to quality programs and applicable regulations, maintaining inspection readiness
• Assess and escalate compliance risks identified through audits to protect subject safety, data integrity, and business continuity
• Lead or support the preparation for and response to regulatory audits and inspections, ensuring adherence to requirements and timely resolution of findings
• Support investigational new drug (IND) applications and related correspondence with global regulatory authorities

Education

• Bachelor's degree in a scientific, allied health, or medical field required; Master's degree preferred

Qualifications

• Minimum of 10 years of progressive experience in the pharmaceutical or biotechnology industry, including at least 5 years in a Clinical Quality Assurance role (or an equivalent combination of PV and QA experience)
• Deep knowledge of global regulations (e.g., FDA, EMA) and guidelines (e.g., ICH, GVP, GxP), including safety reporting requirements
• Broad clinical development experience across all phases (Phase I through BLA/NDA)
• Strong understanding of GCP quality principles spanning preclinical, clinical, and commercial stages
• Proven experience developing and implementing risk-based clinical quality assurance programs
• Demonstrated success leading clinical site and supplier audits, managing regulatory inspections, and responding to findings
• Skilled at effectively communicating quality events and outcomes to internal stakeholders
• Excellent interpersonal, verbal, and written communication skills
• Working knowledge of multiple therapeutic areas is a plus
• Results-oriented, with the ability to set clear objectives, manage competing priorities, and meet dynamic timelines
• Flexible and creative problem solver with a proactive mindset
• Highly collaborative team player who fosters open communication and cross-functional cooperation
• Willingness to travel up to 20% based on business needs

Additional Requirements

• Location: Based in Waltham, MA; remote work not available