Reporting to the VP, Head of Quality, the Senior Director, Quality Assurance, will be responsible for creating/monitoring and maintaining phase appropriate ICH levels of compliance in all our CDMOs, partners, as well as within Kiniksa. The role will assure that Kiniksa's global quality system related to GMP operations and product support leading to batch disposition to market is adhered to and compliant.
This position is responsible for GMP Quality Assurance 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 office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.
Responsibilities (including, but not limited to):
Responsible for developing and leading the GMP Quality Assurance organization.
Provide leadership, guidance, and direction to team and staff consistent with cGMP and cGDP.
Develop Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions and drive risk analysis and mitigation strategies.
As a core member of the Quality Leadership Team (QLT), individual will assist in defining and driving the Quality vision and mindset in close collaboration with other leadership team members.
Oversee all aspects of Quality related to the manufacturing and distribution of Kiniksa Products including managing CMOs from production through distribution.
Responsible for quality oversight for GMP operations (both Commercial and Clinical GMP operations) and distribution to clinic/market (GDP) for clinical and commercial products. Quality oversight will encompass both external GMP operations (ex. CDMOs/partners) as well as internal manufacturing operations (if utilized for any aspect of batch production and shipment).
Management and oversight of the supply chain risk management strategy, including monitoring of third-party logistics provider (3PL) performance.
Manage quality and technical projects with third party suppliers; collaborating with CDMO's to transfer processes and facilitate resolution of quality and technical issues.
Develop and maintain appropriate quality systems to support product release in a compliant and timely manner and routinely monitor performance to established targets.
Ensure appropriate systems and processes are in place for assessing product impact, investigation, follow up and closure of exceptions and audit observations.
Responsible for the evaluation of facilities, procedures, equipment, personnel, and processes to ensure that they consistently deliver product that meets all applicable requirements.
Ensure the timely assessment and investigation of product complaints.
Evaluate and approve compliance documentation including regulatory filings for designated products.
Manage and host Customer audits and Regulatory inspections to assure successful outcomes by proactively collaborating with internal stakeholders to ensure compliant quality system execution by identifying and working to resolve compliance risks and identifying continuous improvements.
Set budgets and identify investments to support and deliver the Quality group Strategic Plan
Drive continuous improvement across the Quality function and entire organization.
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
5+ years of Quality leadership experience with a successful track record in managing external partners and batch certification to market.
Bachelors or Advanced degree in a scientific discipline
Successful track record in managing external partners and batch certification to market
Understanding of worldwide requirements of cGMP and quality systems
In depth knowledge of EU Directives 2001/83/EU, 2001/20/EC, 2003/94/EC, ICH, global GMP/GDP 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 player that has a customer service 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 10%
Salary is commensurate with experience
Kiniksa Benefits Summary - USA
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.