Assoc. Director, Quality - Commercial

The Associate Director, Quality is responsible for providing quality leadership and oversight for all GMP technical transfer activities, including process transfer from development to commercial manufacturing, site‑to‑site transfers, and CMO/CDMO technology transfers. This role ensures that transfers are executed in compliance with global regulatory requirements, company quality standards, and product lifecycle expectations.

The AD serves as the SME for tech transfer, partnering closely with Technical Operations, MS&T, Manufacturing, Supply Chain, Regulatory Affairs, and external partners.

Reporting to the Senior Director, Quality.

This role is based in our Lexington, Massachusetts, USA 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):

• Provide Quality oversight and approval for all GMP technical transfer activities (clinical commercial, site‑to‑site, CMO/CDMO) for both Drug Substance and Drug Product.

• Ensure tech transfer strategies, protocols, reports, and control plans meet GMP, data integrity, and regulatory expectations.

• Act as Quality lead on Tech Transfer Team and ensure timely escalation of quality risks.

• Review and approve process descriptions, CPPs, CQAs, control strategies, and acceptance criteria during transfer.

• Ensure appropriate comparability, validation, and verification strategies are defined and executed.

• Confirm readiness for PPQ, conformance, and commercial launch from a Quality standpoint.

• Approve tech transfer-related GMP documentation, including:

• Tech Transfer Protocols and Final Reports

• Process Validation documents

• Executed Batch Record

• Risk Assessments (FMEA, HACCP, etc.)

• Change Controls, Deviations, and CAPAs

• Ensure transfers align with regulatory filings and submissions (IND, IMPD, NDA/BLA, MAA). Approve regulatory filing documentation supporting tech transfer.

• Provide Quality oversight for CMO/CDMO tech transfers, including:

• Onboarding and qualification

• Audit support

• Quality Agreements and escalation pathways

• Serve as the primary QA point of contact for GMP activities related to tech-transfer, scale-up, process validation/qualification and analytical method validation and transfer

• Execute and support GMP quality Systems, including deviations, investigations, CAPA's, change control, batch review, CPV, OOS/OOT management, and stability programs, ensuring timely and compliant closure

• Participate in regulatory inspections and partner audits related to transferred products.

• Develop and improve Quality Systems, SOPs, and internal guidelines.

• Drive lessons learned, knowledge management, and lifecycle optimization.

• Mentor Quality and cross‑functional team members on tech transfer best practices.

• Host inspections from authorities and customer/partner audits

• Embody Kiniksa's cultural values and align actions with departmental goals and company culture

Qualifications:

• 10+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and quality, or an equivalent combination of training and experience
• Experience in DS and DP manufacturing, tech transfer
• Bachelors or Advanced degree in a scientific discipline
• Successful track record in managing external partners and batch certification to market
• Understanding of worldwide requirements of cGMP and quality systems
• In depth knowledge of EU Directives 2001/83/EU, 2001/20/EC, 2003/94/EC, ICH, global GMP/GDP standards, and Swiss MPLO 812.12.1
• Experience in working with teams in other geographies
• Experience interacting with regulatory health authorities at pre- and post-approval inspections
• Established expertise and training in GxP systems
• Strong team player that has a customer service approach and is solution-oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• 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 10%

The pay range for this position is $186,000 - $200,000. Compensation is subject to change commensurate with industry standards and the candidate's relevant experience and qualifications.

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.