Vice President, Head of Quality

Role Summary

Vice President, Head of Quality. Responsible for creating, monitoring, and maintaining phase-appropriate ICH levels of compliance for all GxP activities associated with Kiniksa products, and for developing, administering, and continuously improving global quality systems to ensure regulatory compliance. Based in Lexington, MA, with in-office work five days a week and a monthly option to work from home on the last Friday.

Responsibilities

• Developing and leading the Quality organization.
• Providing all aspects of Quality support to internal teams and external partners (e.g., CRO, CDMO, CTL).
• Directing the Quality Leadership Team to define and drive the Quality mission and vision.
• Defining Quality objectives and ensuring cross-functional progress and risk mitigation.
• Providing direction and resources to implement the quality vision and deliver corporate goals.
• Overseeing all Quality aspects related to Kiniksa products and third-party GxP providers.
• Developing and maintaining quality systems to support GxP activities and monitoring performance against targets.
• Ensuring systems are in place for assessing product impact and managing exceptions and audit observations.
• Sponsoring quality and technical projects with third-party suppliers and resolving quality/technical issues with internal and external stakeholders.
• Evaluating facilities, procedures, equipment, personnel, and processes to ensure compliance with requirements.
• Evaluating and approving compliance documentation including regulatory filings for designated products.
• Overseeing budget planning and resource allocation to support the Quality group Strategic Plan.
• Collaborating with stakeholders to implement initiatives to improve performance and resilience.
• Representing and aligning actions with Kiniksa‚Äôs cultural values.

Qualifications

• 15+ years‚Äô experience in pharmaceutical/biotech, including drug substance/product manufacture, development, and quality; or equivalent combination of training and experience.
• 15+ years of Quality leadership experience with external partners and internal QA systems in a virtual environment.
• Bachelor‚Äôs or advanced degree in a scientific discipline.
• Strong knowledge of worldwide GxP requirements and quality systems.
• In-depth knowledge of EU Directives 2001/83/EU, 2001/20/EC, 2003/94/EC, ICH, global GxP standards, and Swiss MPLO 812.12.1.
• Experience working with geographically dispersed teams.
• Experience interacting with regulatory health authorities at pre- and post-approval inspections.
• Established expertise and training in GxP systems.
• Strong leadership with a customer-focused, solution-oriented approach.
• Attention to detail and ability to work independently and with cross-functional teams and external partners.
• Commitment to compliance and ethical standards.
• Proficiency with Microsoft Office suite (Word, PowerPoint, Excel, Outlook, SharePoint).
• Ability to travel up to 30%.

Education

• Bachelor‚Äôs or advanced degree in a scientific discipline.