Director, Quality Assurance GMP (Commercial)

Reporting to the Executive Director, Quality, the Director, Quality Assurance GMP will be responsible for GMP quality oversight for Kiniksa's commercial-stage programs, including activities conducted at contract service providers. Scope includes manufacture of cell banks, drug substance, drug product, and labeled drug product. The Director collaborates with Technical Operations, Quality Control, Regulatory Affairs, Supply Chain, and other stakeholders, to support and implement phase-appropriate solutions that protect patient safety, enable programs to advance through commercialization to routine commercial supply, and enhance operational effectiveness.

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):

• Represent Quality Assurance on cross-functional teams, e.g., product development, technology transfer, regulatory dossier preparation, inspection readiness

• Lead and manage a small team of QA professionals, and contribute to their development

• Develop, implement, and improve procedures related to all aspects of GMP manufacturing of commercial materials

• Ensure appropriate quality systems are in place to support product release in a compliant and timely manner, and routinely monitor performance to established targets

• Assist business owners with supplier selection and management

• As required perform supplier qualification and compliance monitoring audits

• Assist in the implementation of quality systems, e.g., deviation, investigation, CAPA, and change control

• Manage Kiniksa's Product Quality Complaint Process; coordinate and conduct product complaint investigations

• Identify and monitor quality system indicators, assuring GMP operations at Kiniksa and contractors are performed in compliance with CGMP

• Prepare for and facilitate regulatory inspections and other external audits

• Perform person-in-Plant functions at CMOs

• Approve master documents e.g. batch records, specifications, etc.

• Evaluate and approve proposed changes in conjunction with change control review board

• Disposition intermediate Products and make recommendations to the Kiniksa Qualified Person for technical release of finished products for Commercial distribution.

• Review and approve complex manufacturing and test records, discrepancy reports, investigations and CAPAs

• Identify and promptly escalate critical risks, and collaborate on quality risk management

• Collaborate with Partners to provide functional expertise in support of commercial stage program opportunities

• Proactively identify improvement opportunities and drive change

• Provide QA support to QC, including lab inspections and method qualification and transfer

Qualifications:

• Requires a minimum of 10+ years of relevant experience in a regulated pharmaceutical industry environment and 3+ years in a Quality Assurance leadership role

• Bachelor's degree in science, engineering, biochemistry or related fields, or its equivalent is required

• Extensive knowledge of US and EU CGMP regulations and guidance

• Strong technical expertise in QA/QC, Manufacturing, and Supply Chain processes

• 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 5%

• 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.