Associate Director, Quality Control – Stabili Position Available In Middlesex, Massachusetts

Associate Director, Quality Control

• Stabili Kiniksa Pharmaceuticals
• 2.

6

Lexington, MA Job Details Full-time Estimated:

$167K

• $228K a year 4 hours ago Qualifications Bachelor of Science 11+ years GMP Bachelor’s degree Quality control Quality systems Senior level Communication skills Full Job Description Associate Director, Quality Control
• Stability and Trending Reporting to the Head of Quality Control, the Associate Director, Quality Control
• Stability and trending, provides oversight for GMP stability programs, supports trending of method and stability data to improve process and product understanding, and to support problem solving and decision making.

Supports internal and external clients across Kiniksa, including Analytical Development, Quality Control, Manufacturing, CMC, Validation, and Quality Systems. Responsibilities (including, but not limited to) : Oversight and management of clinical and commercial stability programs including tracking and trending of stability data, generation of protocols and reports, support test methods, specifications and quality record for GMP Stability program Lead cross functional stability governance team Collaborate with external suppliers for QC deliverables for stability programs Provide and present routine stability metrics Maintain stability LIMS systems as business system owner Routine trending and evaluation of stability data to establish and extend shelf-life of GMP products Evaluate test method and process performance; contribute to preparation of the Annual Product Quality Review for licensed products Recommend controls to assess whether systems operate in a state of control and to identify unexpected results Assure ongoing readiness for regulatory inspection; participate in audits and inspections Contribute to development of specifications and sampling plans Create and improve procedures Verify and maintain the integrity of data used in assessments Document analysis methods and results in compliance with Kiniksa procedures Support management of budget for area of responsibility

Qualifications:

BS in a scientific area with 15+ years experience in Quality Control Experience supporting Quality Control and/or product stability functions Working knowledge of statistical tools, methodologies, and related software, JMP preferred Knowledge of quality systems and domestic and international regulatory requirements Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CTLs Proactive, with a strong desire to engage with clients, and act with urgency and passion Proven ability to work with a high level of integrity, accuracy, and attention to detail Effective verbal and written communication skills Salary is commensurate with experience Kiniksa Benefits Summary

• USA This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position.

This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All employees are expected to adhere to all company policies and act as a role model for company values. 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