Sr. Director, Quality Compliance

Develop and implement a comprehensive, risk-based quality compliance strategy aligned with global regulatory expectations (FDA, EMA, MHRA, ICH).

Provide executive oversight of core quality systems to ensure consistent compliance, operational effectiveness, and continuous improvement.

Serve as a senior quality advisor to executive leadership on compliance risks, trends, and mitigation strategies.

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.

Provide strategic oversight of the global product quality complaint program, ensuring timely investigation, trending, and closure.

Ensure compliance with regulatory reporting requirements, including Field Alert Reports (FARs), Biological Product Deviation Reports (BPDRs), and other post-market obligations.

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.

Serve as inspection lead and primary point of contact for regulatory agency inspections (FDA, EMA, MHRA, and other health authorities).

Oversee inspection preparation, execution, and response, including management of commitments, CAPAs, and remediation activities.

Conduct internal audits and mock inspections to proactively identify and mitigate compliance risks.

Oversee key quality systems including deviations, CAPAs, change control, and quality metrics.

Drive harmonization and optimization of QMS processes and digital platforms (e.g., Veeva, TrackWise).

Establish and monitor quality KPIs to assess system effectiveness and inform executive decision-making.

Champion a culture of quality, accountability, and continuous improvement across the organization.

Lead, develop, and mentor high-performing quality teams across multiple regions.

Collaborate with CMC, Regulatory Affairs, Clinical, Pharmacovigilance, and Supply Chain to ensure integrated quality oversight.

Influence and align stakeholders at all levels to drive compliance and business objectives.

Strategic thinking and enterprise mindset

Executive communication and influence

Risk-based decision making

Change leadership and quality culture transformation

Operational excellence and continuous improvement

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

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.