Manager, Quality GMP

Manager/Senior Manager, Quality GMP (QA)

This role will report to the Director, Quality Assurance, and will support the cGMP activities both internally in Kiniksa's laboratories and at Contract Manufacturing and Testing Organizations, to ensure batch record reviews, analytical test record reviews and associated Quality Processes (i.e. deviations, CAPA, change control, protocols, etc.) are progressed in a compliant and timely manner. The candidate will work with cross functional teams to identify and implement meaningful corrective actions arising from deviations, audit observations and investigations.

This role is based in our Lexington, MA office location. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, but not limited to):

• Perform complex manufacturing formulation batch production record reviews and approval in support of product release in accordance with specifications and SOPs
• Monitor various stages of processing along with the appropriate paperwork in compliance with specifications
• Draft and review specifications and SOPs
• Review and approve quality system documents associated with internal and externally produced or tested biologics products (batch records, test methods, analytical reports, discrepancy reports, investigations, CAPAs, change controls, etc.)
• Support analytical method qualification, method transfer, and lab investigations.
• Assure change control activities are implemented according to approved plans
• Apply strong technical expertise of QA/QC and Manufacturing processes to support development, implementation, and maintenance of cGMP compliant quality systems
• Participate in internal and external audits and regulatory inspections

Qualifications:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred
• A minimum of 5-8+ years of relevant experience in a regulated environment with preferably 3+ years focused on product quality
• Working knowledge of ICH/GxP regulations and expectations
• Understands and can use problem solving tools such as Risk Analysis, Root Cause Analysis and FMEA

Competency Expectations:

• Independently applies advanced level of skills and broad knowledge of diverse related professional fields
• Knowledge of biotech bulk and finished product manufacturing, and analytical testing is preferred.
• Effectively interact with external and contract manufacturer's, testing laboratories, and work as part of an internal multidisciplinary team
• Ability to drive and deliver multiple projects within project scope and timelines
• Good knowledge of US and EU cGMP regulations and guidance
• Experience in utilizing Quality concepts and company objectives to resolve complex issues in an effective manner
• Technical expertise of QA/QC and Manufacturing processes to support development and maintenance of cGMP compliant quality systems
• Reflects solid understanding of strategies, goals and can take part in major parts of projects or provide expert service
• Independently troubleshoots problems and issues; called upon to train, assist or supervise others for a large portion of the job
• Provides consistently prompt, efficient, dependable, highly skilled service
• Demonstrates consistent judgment, quality, accuracy, speed, and creativity
• Detects and resolves problems; assists others with problem resolution; misjudgment may jeopardize compliance
• Takes initiative in making improvement suggestions to promote operational goals on a consistent basis
• Active team member with broader exposure within as well as outside of company
• Facilitates designing processes with Quality built in from the beginning.
• Implements and executes policies, practices, and compliance requirements
• Exercises discretion in referring complex issues and problems
• Good listening and communication skills
• Positive approach
• Proficient in the use of Microsoft Office