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. 

This role is based in Waltham, MA.  

Primary Responsibilities Include:

• 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 and Skills Requirements:

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

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