layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Assoc. Director, Clinical Quality Assurance at Kiniksa Pharmaceuticals

including, but not limited to ): Provide professional expertise and guidance on GCP, GLP and Good Pharmacovigilance Practices (GPV) regulations and other applicable regulations to clinical development teams to proactively identify compliance issues/risks and recommend mitigations
Provides clinical quality strategy
Fosters a collaborative working relationship with key stakeholders (e.g., regional study team members, global clinical operations compliance team members, etc.)
Liaise with various Kiniksa's 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's 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
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
Stays abreast of new and revised government, industry and company regulations, trends and interpretations by participating in trainings, conferences, workshops and discussion groups as appropriate
Other duties as assigned
Stand Out Skills for Impact: Extensive leadership in Clinical Quality Assurance (CQA), driving audit strategy, inspection readiness, and compliance across Phases I–IV in alignment with FDA, EU, and ICH regulations
Deep expertise in GCP, GLP, and Pharmacovigilance (GPV) with a strong focus on risk-based quality management, proactive issue identification, and regulatory compliance
Proven ability to lead audits, inspections, and complex investigations, including root cause analysis and CAPA development to resolve critical quality issues
Collaborative cross-functional partner skilled in influencing stakeholders, improving quality systems (including Veeva), and delivering actionable insights through metrics and reporting

Assoc. Director, Clinical Quality Assurance

Employer job description

Responsibilities (

Qualifications and Experience:

Equal opportunity and accommodations

About this listing

Listing check

Similar jobs

Similar jobs