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HomeCompanies674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001Assoc. Director, Quality - Commercial

Assoc. Director, Quality - Commercial

674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001 · Lexington, MA, US, Lexington, MA · Remote · Active · $186,000–$200,000 / year · ADP Workforce Now Recruiting

Job facts

FieldValue
Company674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001
TitleAssoc. Director, Quality - Commercial
Normalized title-
Department / team-
LocationLexington, MA, United States
Work modelRemote / Remote
Employment type-
Salary$186,000–$200,000 / year
Statusactive
ATS providerADP Workforce Now Recruiting
Posted / first seen2026-04-16 / 2026-05-31
Changed / last seen2026-06-06 / 2026-06-06

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ATS provider jobsActive postings observed through ADP Workforce Now Recruiting.Open
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City jobsActive postings in Lexington.Open
Work model jobsActive Remote postings.Open
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Linked records

Company674a37b7 4b6a 4f38 A5e8 50a609cdab78 19000101 000001
Source4f2fb43e-6107-4f34-ab57-87d29ca5c68a
ATS providerADP Workforce Now Recruiting

Description

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.

Full job record

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Source ID4f2fb43e-6107-4f34-ab57-87d29ca5c68a
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Provideradp_workforcenow
Provider Job Key610536
TitleAssoc. Director, Quality - Commercial
Normalized Title
Statusactive
Activeyes
Location TextLexington, MA, US, Lexington, MA
Department
Team
Employment Type
Workplace Typeremote
Remote Policyremote
CountryUnited States
RegionMA
CityLexington
Salary Raw186000.00 To 200000.00 (USD) Annually
Salary Min186,000
Salary Max200,000
Salary CurrencyUSD
Salary Periodyear
Source URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=674a37b7-4b6a-4f38-a5e8-50a609cdab78&ccId=19000101_000001&lang=en_US&type=JS&jobId=610536&jwId=9201834280576_1
Apply URLhttps://workforcenow.adp.com/mascsr/default/mdf/recruitment/recruitment.html?cid=674a37b7-4b6a-4f38-a5e8-50a609cdab78&ccId=19000101_000001&lang=en_US&type=JS&jobId=610536&jwId=9201834280576_1
First Seen At2026-05-31 18:30:04Z
Last Seen At2026-06-06 11:50:59Z
Last Checked At2026-06-06 11:50:59Z
Last Changed At2026-06-06 11:50:59Z
Inactive At
Source Posted At2026-04-16 13:38:00Z
Source Updated At
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    "requisitionDescription": "<p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;' data-pasted=\"true\"><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">The AD serves as the SME for tech transfer, partnering closely with Technical Operations, MS&amp;T, Manufacturing, Supply Chain, Regulatory Affairs, and external partners.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">Reporting to the Senior Director, Quality.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">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.</span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><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><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Provide Quality oversight and approval for all GMP technical transfer activities (clinical &rarr; commercial, site‑to‑site, CMO/CDMO) for both Drug Substance and Drug Product.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; 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; line-height: 115%; 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; line-height: 115%; 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; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ensure appropriate comparability, validation, and verification strategies are defined and executed.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; 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; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Approve tech transfer&ndash;related GMP documentation, including:<ul style=\"margin-bottom: 0in; margin-top: 0in; font-family: initial; font-size: initial; color: initial;\" type=\"circle\"><li style=\"margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Tech Transfer Protocols and Final Reports</li><li style=\"margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Process Validation documents</li><li style=\"margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Executed Batch Record</li><li style=\"margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Risk Assessments (FMEA, HACCP, etc.)</li><li style=\"margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Change Controls, Deviations, and CAPAs</li></ul></li><li style=\"margin: 0in 0in 8pt; line-height: 115%; 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). Approve regulatory filing documentation supporting tech transfer.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Provide Quality oversight for CMO/CDMO tech transfers, including:<ul style=\"margin-bottom: 0in; margin-top: 0in; font-family: initial; font-size: initial; color: initial;\" type=\"circle\"><li style=\"margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Onboarding and qualification</li><li style=\"margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Audit support</li><li style=\"margin-top: 0in; margin-right: 0in; margin-bottom: 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Quality Agreements and escalation pathways</li></ul></li><li style=\"margin: 0in 0in 8pt; line-height: 115%; 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; line-height: 115%; 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; line-height: 115%; 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; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Develop and improve Quality Systems, SOPs, and internal guidelines.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Drive lessons learned, knowledge management, and lifecycle optimization.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Mentor Quality and cross‑functional team members on tech transfer best practices.</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; 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; line-height: 115%; 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><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\"><strong>Qualifications:</strong></span></p><ul style=\"margin-bottom:0in;margin-top:0in;\" type=\"disc\"><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">10+ years&rsquo; 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</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience in DS and DP manufacturing, tech transfer</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Bachelors or Advanced degree in a scientific discipline</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Successful track record in managing external partners and batch certification to market</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Understanding of worldwide requirements of cGMP and quality systems</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">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</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience in working with teams in other geographies</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Experience interacting with regulatory health authorities at pre- and post-approval inspections</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Established expertise and training in GxP systems</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Strong team player that has a customer service approach and is solution-oriented</li><li style=\"margin: 0in 0in 8pt; line-height: 115%; 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; line-height: 115%; 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; line-height: 115%; 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; line-height: 115%; font-size: 14px; font-family: arial, sans-serif; color: rgb(0, 0, 0);\">Ability to travel up to 10%</li></ul><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:.5in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><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:8.0pt;margin-left:.5in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">The pay range for this position is $186,000 - $200,000. Compensation is subject to change commensurate with industry standards and the candidate&rsquo;s relevant experience and qualifications. </span></p><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><span style=\"font-family: arial, sans-serif; font-size: 14px; color: rgb(0, 0, 0);\">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><p style='margin-top:0in;margin-right:0in;margin-bottom:8.0pt;margin-left:0in;line-height:115%;font-size:16px;font-family:\"Aptos\",sans-serif;'><br></p>\n",
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