Title: Director, Clinical Quality
Location: Hybrid/Flexible in Boston (Must be located in MA)
Position Overview
The Director of Clinical Quality is responsible for leading Clinical Quality Assurance (CQA) activities for assigned clinical development programs. This role oversees audits, manages quality issues, conducts investigations, and ensures inspection readiness. The ideal candidate will have deep expertise in GxP compliance, strong leadership abilities, and excellent communication skills. This position ensures that all studies align with Standard Operating Procedures (SOPs), policies, and global regulatory requirements (e.g., FDA, European Union guidelines).
Key Responsibilities
- Provide expert guidance on GxP, GCP, GLP, and other relevant regulations to clinical development teams, proactively identifying and mitigating compliance risks.
- Collaborate with internal teams and external partners, including contract auditors and investigator sites, to promote quality and consistency across programs.
- Develop and implement a risk-based audit and compliance strategy for assigned programs.
- Conduct and manage domestic and international audits of sites, documents, databases, vendors, and internal systems to ensure GxP compliance with company policies and regulations.
- Assess the impact of audit findings on subject safety, data integrity, and business operations, implementing corrective and preventive actions as needed.
- Lead investigations into significant quality issues, including scientific misconduct and GxP breaches, ensuring proper root cause analysis, corrective action implementation, and regulatory reporting when required.
- Oversee GxP health authority inspections, preparing clinical teams for announced inspections and providing compliance support during regulatory site visits.
- Analyze, report, and present quality metrics to development teams, R&D, and senior management, ensuring necessary actions are taken and monitored for effectiveness.
- Partner with the Clinical Operations team to identify and mitigate cross-functional GxP quality and compliance risks.
- Escalate systemic or critical compliance issues to senior leadership, recommending solutions for both immediate resolution and long-term process improvements.
- Perform additional duties as needed.
Qualifications & Experience
- Bachelor's degree (BA/BS) in biological sciences, engineering, or a related field.
- 12+ years of experience in the pharmaceutical, biotechnology, or healthcare industry.
- In-depth knowledge of GxP, ICH, GMP, and GCP regulations with a solution-based approach to compliance.
- Detail-oriented mindset with a strong commitment to quality and compliance.
- Willingness to travel up to 15% as required.
- Must be local to Massachusetts
