The posting
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. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.
Our ideal candidate is a self-motivated individual who has a passion for clinical quality and can thrive in a fast-paced dynamic environment. 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/or 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 (e.g., United States FDA, European Union Directives, ICH, and National regulations).
Our office-based employees work on an onsite schedule of five days a week onsite in Lexington, MA. While we prioritize in-person teamwork, remote options will be considered for highly qualified individuals who can maintain strong engagement and collaboration in a virtual environment.
Responsibilities (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
Qualifications and Experience:
- 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
- Advanced degree (MS, PhD, MBA) preferred. In lieu of advanced degree, additional years of equivalent experience will be considered
- Auditor certifications a plus
- 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
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Pay Range
$188,000—$204,000 USD
Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.
