Kiniksa Pharmaceuticals · 2 days ago
Associate Director, Clinical Quality Assurance
Lexington, MA
Full-time
Hybrid
Lead/Staff, Director/Executive
$168K/yr - $182K/yr
10+ years expKiniksa Pharmaceuticals is seeking an Associate Director of Clinical Quality Assurance who is a self-motivated individual with a passion for clinical quality. This role is responsible for leading Clinical Quality Assurance activities for clinical development programs, managing audits, quality issues, and ensuring compliance with regulations and company policies.
BiopharmaBiotechnologyMedical
Responsibilities
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 Kiniksas 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 Kiniksas 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 Kiniksas
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
Qualification
Required
B.S degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in clinical quality operations and quality system preferred
Requires solid experience supporting Phases I-IV (particularly Phase III); experience with Regulatory submissions and/or approval
Experience with effectively managing regulatory agency inspection and working with regulators and internal staff to help prepare for inspections is required
Experience developing SOPs, reviewing internal clinical, regulatory and medical processes to ensure they are accurately represented in current SOPs is essential
Broad knowledge of risk-based quality systems approaches consistent with ICH E6 and ICH E8
Previous hands-on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS required
A strong customer focus and ability to prioritize and adapt to business needs are required
Strong business partner with a focus on collaborating and delivering results
Self-motivated, detail oriented, well organized, and able to demonstrate success with managing multiple projects simultaneously and other priorities
Understanding and knowledge of applicable industry regulations
Ability to interact constructively and efficiently within and across functional areas and management
Ability to resolve day-to-day issues efficiently while maintaining compliance
Provide imaginative, thorough, and practical solutions to problems
Solve conflict and address workplace issues in professional and collaborative manner
Preferred
Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered
Auditor certifications a plus
Company
Kiniksa Pharmaceuticals
Kiniksa Pharmaceuticals is developing therapies for inflammatory and autoimmune conditions.
201-500 employees
H1B Sponsorship
Kiniksa Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (3)
2022 (4)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$400MKey Investors
Baker Brothers Advisors LLC
2020-05-13Post Ipo Equity· $80M
2018-05-23IPO
2018-02-01Series C· $200M
Leadership Team
Eben Tessari
Chief Operating Officer
Aaron Young
Senior Vice President, Chief Intellectual Property Officer
Recent News
2025-12-09
2025-10-29
2025-10-29
Company data provided by crunchbase