Associate Director, Clinical Quality Assurance

Role Summary

Associate Director, Clinical Quality Assurance leads Clinical Quality Assurance activities for clinical development programs, including management of audits, quality issues and investigations, and inspections. Requires in-depth experience in GCP and compliance, with leadership and communication skills to operate independently. Oversees GCP, GLP and PV activities and ensures studies comply with SOPs, policies, and applicable worldwide regulations. Based in Lexington, MA with a hybrid schedule (4 days in office, 1 day remote; remote arrangements considered for highly qualified candidates).

Responsibilities

• Provide professional expertise and guidance on GCP, GLP and GPV regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
• Provide clinical quality strategy
• Foster collaborative relationships with key stakeholders
• Liaise with Kiniksas functions and external parties to promote quality and consistency; develop risk-based audit and compliance strategy; assist project teams with CAPAs; enable inspection readiness
• Support GCP audit program including routine and non-routine quality assurance audits of sites, vendors, processes, systems, and study documents
• Support Oversight of the Commercial Pharmacovigilance Program
• Develop and implement program-specific risk-based audit and compliance strategy and manage audits in line with GCP/GLP/GPV policies
• Lead investigations into significant quality issues; identify root cause and CAPA; track actions and report violations to regulators as needed
• Lead and support GCP/GLP/GPV health authority inspections; prepare teams for inspections and provide technical support during inspections
• Provide Clinical QA oversight of GCP protocols, ICFs, CSRs, and other trial documents as requested
• Analyze, report, and present metrics for assigned programs; recommend actions and monitor implementation
• Collaborate with Quality team to identify and mitigate quality/compliance issues across programs
• Escalate systemic problems to senior management and propose solutions for immediate and long-term resolution
• Stay abreast of regulatory changes and industry trends through trainings and discussions
• Other duties as assigned

Qualifications

• B.S. in life sciences with 10+ years of progressive global quality/regulatory compliance experience in pharma/biotech or medical device industries; hands-on clinical quality operations experience preferred
• Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of experience considered
• Auditor certifications a plus
• Solid experience supporting Phases I-IV (particularly Phase III); experience with regulatory submissions/approvals
• Experience managing regulatory agency inspections and collaborating with regulators and internal staff
• Experience developing SOPs and ensuring clinical/regulatory processes are reflected in SOPs
• Knowledge of risk-based quality systems (ICH E6, ICH E8)
• Experience with Veeva Quality Docs, Veeva Training, and Veeva QMS
• Strong customer focus, ability to prioritize and adapt to business needs
• Strong business partnership, collaborative mindset, and results-oriented
• Self-motivated, detail-oriented, organized, and capable of managing multiple projects
• Understanding of applicable industry regulations and ability to work across teams
• Ability to resolve day-to-day issues while maintaining compliance; provide practical solutions and handle conflicts professionally

Education

• B.S. degree in life sciences
• Advanced degree (MS, PhD, MBA) preferred