New · posted Oct 15
Kiniksa Pharmaceuticals International · Pharmaceuticals
Senior Director, Quality Compliance
- Lexington, MA
- On-site
- Full-time
- Director
Open until filled
The role
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.
We're seeking a Senior Director, Quality Compliance reporting to the VP, Head of Quality, who will be responsible for providing strategic leadership and oversight of the organization’s global quality compliance programs, ensuring alignment with regulatory requirements and industry best practices. This role leads key quality systems including supplier oversight, product complaints, and inspection readiness, and partners cross-functionally to drive a proactive, risk-based quality culture that supports development through commercialization.
This role is based in our Lexington, MA office and requires employees to be onsite five days per week.
What you need
Standout Skills for Impact
- Spearhead quality compliance strategy and governance
- Owns and governs enterprise-wide supplier & external partner oversight
- Drives uncompromising excellence with a patient-first mindset
- Leads collaborative resolution of complex, cross-functional challenges
Qualifications and Experience
- Advanced degree in a scientific discipline (MS, PhD, or equivalent preferred).
- 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.
- Extensive experience with regulatory inspections and health authority interactions.
- 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.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
What you'll do
Responsibilities (including, but not limited to)
- 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.
- Strategic thinking and enterprise mindset
- Executive communication and influence
- Risk-based decision making
- Change leadership and quality culture transformation
- Operational excellence and continuous improvement
- 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.
Pay
$250,000 – $273,000 a year
Employer provided$250,000—$273,000 USD
Where you'll work
Lexington, MAOn-siteOpen in Maps (opens in a new tab)
More jobs in Lexington, MAEqual opportunity, accessibility and legal noticesKiniksa Pharmaceuticals International's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 25% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Director roles in Massachusetts33 roles publishing pay
Director roles in the US102 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $250,000 | — | $273,000 |
| Massachusetts (middle half) | $186,000 | $204,500 | $231,000 |
| All US (middle half) | $186,500 | $209,250 | $231,375 |
This role: Kiniksa Pharmaceuticals International's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not Kiniksa Pharmaceuticals International's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 43 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance17
- Collaboration and leadership14
- Quality systems and risk12
- Investigations and CAPA7
- Regulatory submissions2
- Data and digital systems2
- Documentation and SOPs1
- Validation and qualification1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 58 (GLP)(official source, opens in a new tab)Good laboratory practice for nonclinical laboratory studies
- ICHICH quality guidelines(official source, opens in a new tab)Q1 stability, Q2(R2) analytical validation, Q7, Q9 risk management, Q10 quality systems
- ICHICH E6 good clinical practice(official source, opens in a new tab)The international standard for the conduct of clinical trials
Company hiring pulse
Kiniksa Pharmaceuticals International on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 1
- Locations
By discipline
- Quality4 80%
- Compliance & Safety1 20%
By level
- Director3 60%
- Senior & Principal1 20%
- Associate & Specialist1 20%
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Senior Director, Quality Compliance at Kiniksa Pharmaceuticals International
Open until filled. $250K–$273K a year, employer provided.