Assoc. Director, Clinical Quality Assurance Lexington, MA

Assoc. Director, Clinical Quality Assurance

Lexington, MA

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders.

The Associate Director GCP Quality is responsible for leading Clinical Quality Assurance (CQA) activities for clinical development programs, including the management of audits, quality issues and investigations, and inspections. This position requires a depth of understanding and significant experience in GCP and compliance, leadership, and communication skills to conduct responsibilities independently. This role is accountable for Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Pharmacovigilance (PV) oversight, and for assuring the compliance of studies with our Company’s Standard Operating Procedures (SOPs), policies, and all applicable worldwide regulations and guidelines.

• Provide professional expertise and guidance on GCP, GLP, and Good Pharmacovigilance Practices regulations and other applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
• Provide clinical quality strategy
• Foster a collaborative working relationship with key stakeholders (e.g., regional study team members, global clinical operations compliance team members, etc.)
• Liaise with various Kiniksa functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and within programs; develop the risk‑based audit and compliance strategy for programs; assist project teams in implementing corrective and preventive actions; and enable teams to be inspection ready, in support of a culture of sustainable compliance
• Support GCP audit program to include routine and non‑routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines
• Support Oversight of the Commercial Pharmacovigilance Program
• Develop and implement program‑specific risk‑based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP/GLP/GPV and Kiniksa policies and procedures
• Lead investigations into significant quality issues, scientific misconduct and serious breach of GCP/GLP/GPV, if they occur; facilitate identification of root cause and development of appropriate corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities
• Lead and support GCP/GLP/GPV health authority inspections; lead clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and Kiniksa
• Provide Clinical QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested
• Analyze, report, and present metrics for assigned programs to development teams, R&D, and Quality management; recommend any required actions and monitor implementation
• Collaborate with Quality team to identify and mitigate GCP/GLP/GPV quality and compliance issues with potential impact across multiple programs or functional groups
• Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long‑term resolution
• Stay abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings,…