Kiniksa Pharmaceuticals
Associate Director, Clinical Quality Assurance
Kiniksa Pharmaceuticals, Lexington, Massachusetts, United States, 02173
Associate Director, Clinical Quality Assurance
Join to apply for the
Associate Director, Clinical Quality Assurance
role at
Kiniksa Pharmaceuticals .
Base pay range: $168,000.00/yr – $182,000.00/yr. This range is provided by Kiniksa Pharmaceuticals; actual pay is based on skills, experience, and market benchmarks.
Our ideal candidate is a self‑motivated individual with a passion for clinical quality who can thrive in a fast‑paced, dynamic environment. The Associate Director leads Clinical Quality Assurance (CQA) activities for clinical development programs, managing audits, quality issues, investigations, and inspections. The role requires in‑depth understanding of GCP/GLP/PV, leadership, communication, and the ability to work independently. Accountability involves GCP, GLP, and PV oversight, ensuring studies comply with SOPs, policies, and worldwide regulations (FDA, EU Directives, ICH, national regulations).
Location & Schedule Based in Lexington, MA. Employees follow a hybrid schedule: 4 days in the office and 1 day remote. Remote arrangements may be considered for highly qualified individuals.
Responsibilities
Provide expertise and guidance on GCP, GLP, and Good Pharmacovigilance Practices (GPV) regulations to clinical development teams, proactively identifying compliance issues/risks and recommending mitigations.
Develop and implement clinical quality strategy.
Foster collaborative relationships with key stakeholders.
Coordinate with Kiniksa functions and external parties (contract auditors, investigator sites) to promote high quality and consistency across programs; develop risk‑based audit and compliance strategy; assist teams in implementing corrective and preventive actions; enable inspection‑readiness.
Support the GCP audit program, including routine and non‑routine QA audits of clinical investigator sites, vendors, processes, systems, and study documents.
Support oversight of the Commercial Pharmacovigilance Program.
Lead investigations into significant quality issues, scientific misconduct, and serious breaches of GCP/GLP/GPV; facilitate root‑cause analysis and corrective actions; track and confirm effectiveness; ensure reporting to regulatory authorities.
Lead and support GCP/GLP/GPV health authority inspections; lead teams in inspection preparation and provide technical support during inspections.
Provide Clinical QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other trial documents as requested.
Analyze, report, and present metrics for assigned programs; recommend actions and monitor implementation.
Collaborate with the Quality team to identify and mitigate quality and compliance issues with cross‑program impact.
Escalate systemic or critical problems and recommend solutions to senior management.
Stay abreast of new and revised regulations, trends, and interpretations through trainings, conferences, workshops, and discussion groups.
Perform other duties as assigned.
Qualifications & Experience
B.S. degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, preferably in clinical quality operations and quality system roles.
Advanced degree (MS, PhD, MBA) preferred; additional equivalent experience considered.
Auditor certifications a plus.
Solid experience supporting Phases I–IV, particularly Phase III; experience with regulatory submissions and/or approval.
Experience managing regulatory agency inspections and working with regulators and internal staff.
Experience developing SOPs and reviewing internal processes to ensure accurate representation in current SOPs.
Broad knowledge of risk‑based quality systems approaches consistent with ICH E6 and ICH E8.
Hands‑on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS.
Strong customer focus, ability to prioritize and adapt to business needs.
Effective business partnering and results delivery.
Self‑motivated, detail‑oriented, well organized, and able to manage multiple projects simultaneously.
Understanding of applicable industry regulations.
Constructive and efficient interaction within and across functional areas and management.
Capacity to resolve day‑to‑day issues efficiently while maintaining compliance.
Creative, practical problem solving.
Conflict resolution and professional workplace collaboration.
Benefits Summary Details available upon request.
Equal Opportunity Statement Kiniksa is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status. Reasonable accommodation is available for individuals with disabilities.
Employment Type Full‑time
Seniority Level Director
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Associate Director, Clinical Quality Assurance
role at
Kiniksa Pharmaceuticals .
Base pay range: $168,000.00/yr – $182,000.00/yr. This range is provided by Kiniksa Pharmaceuticals; actual pay is based on skills, experience, and market benchmarks.
Our ideal candidate is a self‑motivated individual with a passion for clinical quality who can thrive in a fast‑paced, dynamic environment. The Associate Director leads Clinical Quality Assurance (CQA) activities for clinical development programs, managing audits, quality issues, investigations, and inspections. The role requires in‑depth understanding of GCP/GLP/PV, leadership, communication, and the ability to work independently. Accountability involves GCP, GLP, and PV oversight, ensuring studies comply with SOPs, policies, and worldwide regulations (FDA, EU Directives, ICH, national regulations).
Location & Schedule Based in Lexington, MA. Employees follow a hybrid schedule: 4 days in the office and 1 day remote. Remote arrangements may be considered for highly qualified individuals.
Responsibilities
Provide expertise and guidance on GCP, GLP, and Good Pharmacovigilance Practices (GPV) regulations to clinical development teams, proactively identifying compliance issues/risks and recommending mitigations.
Develop and implement clinical quality strategy.
Foster collaborative relationships with key stakeholders.
Coordinate with Kiniksa functions and external parties (contract auditors, investigator sites) to promote high quality and consistency across programs; develop risk‑based audit and compliance strategy; assist teams in implementing corrective and preventive actions; enable inspection‑readiness.
Support the GCP audit program, including routine and non‑routine QA audits of clinical investigator sites, vendors, processes, systems, and study documents.
Support oversight of the Commercial Pharmacovigilance Program.
Lead investigations into significant quality issues, scientific misconduct, and serious breaches of GCP/GLP/GPV; facilitate root‑cause analysis and corrective actions; track and confirm effectiveness; ensure reporting to regulatory authorities.
Lead and support GCP/GLP/GPV health authority inspections; lead teams in inspection preparation and provide technical support during inspections.
Provide Clinical QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other trial documents as requested.
Analyze, report, and present metrics for assigned programs; recommend actions and monitor implementation.
Collaborate with the Quality team to identify and mitigate quality and compliance issues with cross‑program impact.
Escalate systemic or critical problems and recommend solutions to senior management.
Stay abreast of new and revised regulations, trends, and interpretations through trainings, conferences, workshops, and discussion groups.
Perform other duties as assigned.
Qualifications & Experience
B.S. degree in life sciences with 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, preferably in clinical quality operations and quality system roles.
Advanced degree (MS, PhD, MBA) preferred; additional equivalent experience considered.
Auditor certifications a plus.
Solid experience supporting Phases I–IV, particularly Phase III; experience with regulatory submissions and/or approval.
Experience managing regulatory agency inspections and working with regulators and internal staff.
Experience developing SOPs and reviewing internal processes to ensure accurate representation in current SOPs.
Broad knowledge of risk‑based quality systems approaches consistent with ICH E6 and ICH E8.
Hands‑on experience with Veeva Quality Docs, Veeva Training, and Veeva QMS.
Strong customer focus, ability to prioritize and adapt to business needs.
Effective business partnering and results delivery.
Self‑motivated, detail‑oriented, well organized, and able to manage multiple projects simultaneously.
Understanding of applicable industry regulations.
Constructive and efficient interaction within and across functional areas and management.
Capacity to resolve day‑to‑day issues efficiently while maintaining compliance.
Creative, practical problem solving.
Conflict resolution and professional workplace collaboration.
Benefits Summary Details available upon request.
Equal Opportunity Statement Kiniksa is an Equal Opportunity employer and will consider you without regard to race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status. Reasonable accommodation is available for individuals with disabilities.
Employment Type Full‑time
Seniority Level Director
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