Associate Director, Supplier Quality Management (SQM)

Kiniksa Pharmaceuticals

Kiniksa Pharmaceuticals

Quality Assurance
Posted on Wednesday, June 5, 2024

Reporting to the Executive Director, Quality, the Associate Director, Supplier Quality Management (SQM), will be responsible for directing the overall SQM strategy as well ensuring execution of SQM activities and improving SQM processes. This role will collaborate with all global GxP groups (Good Clinical, Manufacturing, and Distribution practices) to provide appropriate supplier oversight and relationship management.

This role is based in our London 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):

  • Establish, maintain, and improve core SQM processes and systems.
  • Educate Kiniksa personnel and proactively engage with key internal stakeholders to assure the smooth functioning of Kiniksa business operations with respect to suppliers of GxP materials and services.
  • Lead the SQM team to ensure compliant and on-time execution of SQM activities, such as, but not limited: global GxP supplier oversight, audit deliverables, supplier change notifications (SCN), damaged defective raw materials (DDRM), SQM system improvements, and monitoring supplier risks
  • Secure appropriate agreements (e.g., Confidentiality, Quality Technical) with audit firms and global GxP vendors
  • Perform risk-based evaluation of Kiniksa supply chain to determine and execute compliant and timely selection, qualification, and oversight; escalate critical risks to senior management
  • Represent Kiniksa as the core business owner for the SQM program driving improvement activities, ensuring business continuity and presenting SQM topics during inspections and audits with successful outcomes
  • Ensure that SQM processes are designed and operating in a way to provide appropriate support in all GxP areas of the company
  • Act as a key interface to the Supply Chain/Supplier Relationship Management function(s) in working with the various suppliers across the Kiniksa Supply Chain portfolio
  • Monitor industry compliance trends with the various regulatory agencies as it relates to supplier oversight
  • Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions and drive risk analysis and mitigation strategies
  • Apply appropriate metrics to monitor the performance of key vendors. Collaborate with business owners to improve and verify performance.
  • Ensure appropriate systems are in place for follow up and closing investigations and audit observations
  • Independently apply advanced level of skill and broad knowledge of diverse related professional fields

Qualifications:

  • 8+ years of relevant experience in a regulated pharmaceutical environment and 3 years focused on GxP Audit.
  • Bachelor's degree in science, engineering, biochemistry or related fields, or its equivalent is required.
  • Extensive knowledge of US and EU CGxP regulations and guidance
  • Strong technical expertise in QA, Manufacturing and Clinical environments.
  • Demonstrated strong written and verbal communication skills
  • Proven mindset of proactive continuous improvement
  • Efficient independent worker with ability to focus and drive for results
  • Strong attention to detail
  • Ability to work in a fast paced-environment and to handle multiple tasks
  • 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.