Kiniksapharmaceuticals
Senior Director, Quality Compliance
Lexington, MA · Director
Sponsorship not specified$250k-$273kDetected 22 days ago
GCPNegotiationAuditingSupply ChainPerformance ManagementGMPFDA RegulatoryPharmacovigilanceLeadershipCommunicationGxPRegulatory Affairs
About the role
- 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.
- This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
Responsibilities
- Develop and implement a comprehensive, risk-based quality compliance strategy aligned with global regulatory expectations (FDA, EMA, MHRA, ICH).
- Establish and maintain a robust global supplier quality management program for CMOs, CROs, and critical vendors.
- Oversee qualification, auditing, performance monitoring, and ongoing compliance of external partners.
- Lead development and negotiation of quality agreements to clearly define roles, responsibilities, and compliance expectations.
- Drive vendor performance management through KPIs, risk assessments, and governance forums.
- Drive continuous improvement in complaint handling processes, including root cause analysis and CAPA effectiveness.
- Partner with manufacturing, supply chain, and regulatory teams to mitigate product quality risks and prevent recurrence.
- Lead global inspection readiness strategy, ensuring a continuous state of readiness across all GxP areas.
- Drive harmonization and optimization of QMS processes and digital platforms (e.g., Veeva, TrackWise).
- Lead, develop, and mentor high-performing quality teams across multiple regions.
Requirements
- 12+ years of experience in Quality Assurance/Compliance within the pharmaceutical or biotechnology industry.
- Demonstrated leadership experience in GMP, GCP, and/or GLP environments across development and commercial stages.
- Proven expertise in supplier quality management, product complaints, and inspection readiness.
- Strong knowledge of global regulatory requirements and guidelines (FDA, EMA, ICH).
- Experience with electronic Quality Management Systems (e.g., Veeva, TrackWise)
- Up to 30% travel required.
Nice to have
- Advanced degree in a scientific discipline (MS, PhD, or equivalent preferred).
Skills
- Spearhead quality compliance strategy and governance
- Drives uncompromising excellence with a patient-first mindset
- Leads collaborative resolution of complex, cross-functional challenges
Compensation
- $250,000 - $273,000 USD
- 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.
Benefits
- Serve as inspection lead and primary point of contact for regulatory agency inspections (FDA, EMA, MHRA, and other health authorities).
- decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
Equal opportunity
- Please contact us to request accommodation.
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