Associate Director, GMP Quality Assurance Operations

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    "requisitionDescription": "<div><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;' data-pasted=\"true\"><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">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&rsquo;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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">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.</span></p><p style='margin-top:12.0pt;margin-right:0in;margin-bottom:12.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\"><strong>Responsibilities <em>(including, but not limited to)</em>:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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&rsquo;s Quality System</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Support batch record review, disposition, and release activities for clinical materials, in accordance with established procedures; support QP/RP interactions and governance where applicable</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Provide hands-on QA oversight of CDMO&rsquo;s and key suppliers supporting development programs, including qualifications, audits, QTA, issue management and performance monitoring</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Execute and support GMP quality Systems, including deviations, investigations, CAPA&rsquo;s, change control, batch review, CPV, OOS/OOT management, and stability programs, ensuring timely and compliant closure</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Support review of CMC sections for IND&rsquo;s, IMPD&rsquo;s, BLA&rsquo;s and MAA&rsquo;s and support responses to health authority questions.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Contribute to quality risk management activities by identifying, assessing, and escalating GMP-related risks, propose mitigation strategies in partnership with Quality Management</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Support labeling/packaging operations, temperature excursions, managing QP Declarations and Certification activities and QP release co-ordination activities, as applicable.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Track and report program-level GMP quality metrics and trends; support continuous improvement initiatives across manufacturing operations.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ensure tech transfer strategies, protocols, reports, and control plans meet GMP, data integrity, and regulatory expectations.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Act as Quality lead on Tech Transfer Team and ensure timely escalation of quality risks.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Review and approve process descriptions, CPPs, CQAs, control strategies, and acceptance criteria during transfer.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Confirm readiness for PPQ, conformance, and commercial launch from a Quality standpoint.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ensure transfers align with regulatory filings and submissions (IND, IMPD, NDA/BLA, MAA).</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Participate in regulatory inspections and partner audits related to transferred products.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Host inspections from authorities and customer/partner audits</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Embody Kiniksa&rsquo;s cultural values and align actions with departmental goals and company culture</li></ul></div><p style='margin-top:12.0pt;margin-right:0in;margin-bottom:12.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;text-align:justify;line-height:normal;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\"><strong>Qualifications:</strong></span></p><div style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;'><ul style=\"margin-bottom:0in;list-style-type: disc;\"><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Hands-on experience supporting biologics manufacturing, including drug substance and drug product operations.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience supporting GMP technical transfer activities, including late‑stage manufacturing transfers and CDMO technology transfers.</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong working knowledge of global GMP regulations and guidance (FDA, EMA, ICH) and phase-appropriate application for clinical-stage biologics</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Proven experience providing QA oversight of internal manufacturing for early stage and CDMO&rsquo;s and external QC labs, including audits, investigations, change management, and issue resolution</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Solid understanding of validation principles and batch release processes&nbsp;</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience in working with teams in multiple geographies</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong commitment to compliance and ethical standards</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.)</li><li style=\"margin: 0in 0in 8pt; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ability to travel up to 15%&nbsp;</li></ul></div><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\"><span style=\"font-size:inherit;\" data-pasted=\"true\">The pay range for this position is $160,000 - $200,000. Compensation is subject to change commensurate with industry standards and the candidate&rsquo;s relevant experience and qualifications.&nbsp;</span></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\"><br></span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:0in;margin-left:0in;font-size:11.0pt;font-family:\"Calibri\",sans-serif;line-height:normal;background:white;'><span style=\"color: rgb(0, 0, 0); font-family: arial, sans-serif; font-size: 14px;\">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.</span></p></div>\n",
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