Kiniksa is seeking an experienced Associate Director, GMP Quality Assurance Operations to be a key leader within the Quality organization, responsible for providing hands-on-Quality Operations oversight for GMP manufacturing activities supporting clinical programs. This individual will oversee quality activities across the manufacture of master cell bank, working cell bank, drug substance and drug product/finished goods. The role is accountable for quality oversight of internal early-phase manufacturing operations and external manufacturing at CDMO's for late-phase programs. This role will partner with cross-functional teams to ensure phase-appropriate GMP compliance, effective execution of quality systems, and continuous inspection readiness in support of clinical development objectives.
This role is also responsible for supporting late-stage 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.
Reporting to the Senior Director, Quality. 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):
- Lead and execute GMP QA activities for development programs, including manufacture of master cell bank, working cell bank, drug substance and drug product/finished goods, in alignment with Kinika's Quality System
- Support batch record review, disposition, and release activities for clinical materials, in accordance with established procedures; support QP/RP interactions and governance where applicable
- Provide hands-on QA oversight of CDMO's and key suppliers supporting development programs, including qualifications, audits, QTA, issue management and performance monitoring
- 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
- Partner closely with CMC, Technical Operations, Analytical Sciences, Quality Control, and Supply Chain, and Regulatory teams to integrate quality oversight into program execution and manufacturing timelines
- Support review of CMC sections for IND's, IMPD's, BLA's and MAA's and support responses to health authority questions.
- Contribute to quality risk management activities by identifying, assessing, and escalating GMP-related risks, propose mitigation strategies in partnership with Quality Management
- Support labeling/packaging operations, temperature excursions, managing QP Declarations and Certification activities and QP release co-ordination activities, as applicable.
- Track and report program-level GMP quality metrics and trends; support continuous improvement initiatives across manufacturing operations.
- Provide Quality oversight and approval for GMP technical transfer activities (clinical to 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.
- Confirm readiness for PPQ, conformance, and commercial launch from a Quality standpoint.
- Approve tech transfer related GMP documentation, including but not limited to: Tech Transfer Protocols and Final Reports, Process Validation documents, Risk Assessments and change controls.
- Ensure transfers align with regulatory filings and submissions (IND, IMPD, NDA/BLA, MAA).
- Participate in regulatory inspections and partner audits related to transferred products.
- Host inspections from authorities and customer/partner audits
- Embody Kiniksa's cultural values and align actions with departmental goals and company culture
Qualifications:
- Bachelors in scientific discipline or a related discipline, advanced degree preferred, a minimum of 8 years of progressive experience in GMP QA withing biotech or pharmaceutical development.
- Hands-on experience supporting biologics manufacturing, including drug substance and drug product operations.
- Experience supporting GMP technical transfer activities, including late‑stage manufacturing transfers and CDMO technology transfers.
- Strong working knowledge of global GMP regulations and guidance (FDA, EMA, ICH) and phase-appropriate application for clinical-stage biologics
- Proven experience providing QA oversight of internal manufacturing for early stage and CDMO's and external QC labs, including audits, investigations, change management, and issue resolution
- Solid understanding of validation principles and batch release processes
- Experience in working with teams in multiple geographies
- 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 15%
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.