Associate Director, Quality Control

Reporting to the Head of Quality Control, the Associate Director, Quality Control, will lead the timely and compliant analysis of commercial and late-stage clinical products. The role involves deep technical and logistical collaboration across the Kiniksa organization, and with contract testing laboratories (CTLs). The incumbent will oversee activities to assure Quality Control delivers planned analytical activities in accordance with agreed scope, timing and budget.

Responsibilities (including, but not limited to):

• Design, implement, and continually improve Kiniksas Quality Control programs for commercial and late-stage clinical drug products, including combination products.
• Assure timely and accurate testing at Kiniksa and Kiniksas CTLs in compliance with CGMP, established procedures and regulatory applications.
• Select and qualify suppliers and CTLs; establish standards and measure performance.
• Assure ongoing readiness for regulatory inspection; participate in audits and inspections.
• Collaborate with internal and external partners to identify opportunities and risks, and facilitate and measure continuous improvement.
• Establish and maintain sampling plans and specifications; collaborate on preparation of justification of specifications.
• Collaborate on the phase-appropriate qualification/validation, and transfer of methods.
• Assure all personnel performing Quality Control analysis and managing data for Kiniksa are appropriately trained and qualified.
• Collaborate on the qualification of internal reference standards; maintain the reference standard program across Kiniksa laboratories and CTLs.
• Monitor and trend method and product data.
• Enable the timely completion of Quality System records associated with sample testing to improve reliability of test methods, facilitate change, and evaluate and prevent exceptions (change control, lab investigations, OOS, deviations, and CAPAs).
• Review and approve laboratory data and results, assuring their traceability and integrity.
• Generate Certificates of Analysis for product release, and other certificates of GMP testing.
• Assure availability of critical reagents and other essential materials.
• Prepare regulatory application content.

Qualifications:

• Requires an BS or MS in Analytical Chemistry, Biochemistry or related field with 6+ years experience in Quality Control or Analytical Development roles for biologics.
• Working knowledge of quality systems and domestic and international regulatory requirements.
• Familiarity with a wide range of test methods needed for evaluation of diverse samples, such as cell banks, drug substance, drug product, combination products, and raw materials.
• Large molecule experience is preferred.
• Experience with oversight of CTLs.
• Experience with phase-appropriate method qualification, validation and transfer.
• Experience conducting laboratory and OOS/OOT investigations.
• Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including contract testing laboratories.
• Experience with data trending and statistical programs (e.g., JMP, Excel, etc.) preferred.
• Experience conducting and leading audits is a plus.
• Ability to build and maintain positive and collaborative relationships with management, peers, and team, and externally with third party contract organizations.
• Self-motivated, with the ability to act with urgency and passion.
• Proven ability to work with a high level of integrity and accuracy.
• Strong organizational skills.
• Excellent verbal and written communication skills to effectively interface with regulatory authorities, partners and suppliers, and all levels of internal management.
• Entrepreneurial, enjoys working in a fast-paced, small-company environment.
• Occasional domestic travel to third parties may be needed.
• Ability to travel up to 25%.

Salary is commensurate with experience.

The expected salary range for Associate Director, Quality Control is $171,000 - $189,000 annually. Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

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.