Vice President, Head of Quality

Reporting to the SVP, Chief Financial Officer, the Vice President, Head of Quality, will be responsible for creating/monitoring and maintaining phase appropriate ICH levels of compliance for all GxP activities associated to Kiniksa product. This includes, though not limited to, the development, administration, and continuous improvement of Kiniksa global quality systems associated with all GxP operations to ensure organizational compliance with regulatory requirements.

This position is responsible for all Quality and requires significant collaboration cross-functionally and with CDMOs and other outsourced companies providing functional expertise.

This role is based in our Lexington, MA Office. Our VP Level office-based employees follow a schedule of 5 days a week in the office, with the opportunity to work from home the last Friday of every month.

Responsibilities (including, but not limited to):

• Responsible for developing and leading the Quality organization.
• Responsible for all aspects of Quality support, both internal and external (i.e., CRO, CDMO, CTL, etc.) to Kiniksa.
• Directs the Quality Leadership Team (QLT) to define and drive the Quality mission and vision, establishing a Quality mindset across the organization in close collaboration with the Executive Leadership Team.
• Defines Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions and drive risk analysis and mitigation strategies.
• Provides direction, guidance, and resources to the Quality team to facilitate the implementation of the quality vision and mission and to deliver the corporate goals.
• Oversees all aspects of Quality related to Kiniksa Products, ensuring adequate quality oversight and management of Third Party GxP providers.
• Develops and maintains appropriate quality systems to support Kiniksa’s GxP activities and routinely monitor performance of the quality system to established targets.
• Assures appropriate systems and processes are in place for assessing product impact, investigation, follow up and closure of exceptions and audit observations.
• Sponsors quality and technical projects with third party suppliers; collaborating with internal stakeholders and GxP partners to facilitate resolution of quality and technical issues.
• Oversees the evaluation of facilities, procedures, equipment, personnel, and processes to ensure that they consistently deliver product that meets all applicable requirements.
• Evaluates and approve compliance documentation including regulatory filings for designated products. 
• Oversees and set budgets, identifying investments and resources to support and deliver the Quality group Strategic Plan
• Collaborates with stakeholders to identify and implement initiatives to improve performance, staff knowledge and organizational resilience.
• Embodies Kiniksa’s cultural values and aligns daily actions with departmental goals and company culture.

Qualifications:

• 15+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality, or an equivalent combination of training and experience 
• 15+ years of Quality leadership experience with a successful history in managing external partners as well as internal QA systems in a virtual environment
• Bachelors or Advanced degree in a scientific discipline
• Strong knowledge of worldwide requirements for GxP 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 in working with teams in other geographies
• Experience interacting with regulatory health authorities at pre- and post-approval inspections
• Established expertise and training in GxP systems
• Strong team leader that has a customer focus approach and is solution-oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)
• Ability to travel up to 30% 

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.