Jobot
Associate Director, Quality Operations (Biologics)
Jobot, Boston, Massachusetts, us, 02298
Bonus + Equity + REMOTE
This Jobot Job is hosted by: Katie GriffithAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $160,000 - $190,000 per year
A bit about us:
We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatment for patients.
Why join us?Competitive SalaryAnnual BonusEquity (RSUs)401k ProgramREMOTEHealth BenefitsCommercial DrugJob Details
We are looking for an Associate Director of Quality Operations who will provide laboratory QA support for our biologics commercial and clinical development programs by working closely with our various contract development and manufacturing organizations.
Our Quality Operations team consists of Lab QA, Manufacturing QA, and GMP/GDP Compliance functions. They are responsible for supporting all biologics CMC programs in compliance with our established procedures, cGMP, regulatory submissions, quality agreements, and other applicable guidelines and regulations.
Responsibilities:
Vendor management of contract laboratories. Facilitate routine external meetings, coordinate planning and delivery of testing results, lead implementation, and manage issue resolution.Review testing execution by CDMOs/CTLs, generate internal COAs, produce batch analysis and stability tables, and respond to emerging trend performance of drug substance and drug product across clinical and commercial CMC programsCapture records in Veeva for QMS activity at CDMO/CTLs, such as quality events, deviations, investigations, OOS/OOT, CAPA, Effectiveness checks, etc.Collaborate with Analytical Development group as needed, seeking additional technical support for test method implementation, troubleshooting, performance monitoring, and OOS/OOT investigationsDrive change management in Veeva for implementation and modification of Quality testing related lifecycle documents (i.e. test methods, specifications, stability protocols, and related technical documents)Design and lead new initiatives and process improvements to Laboratory QA processes, including business tools, escalation norms, communication piecesAuthor, review, or approve lifecycle documents governing the Laboratory QA function, including SOPs, analytical methods, specifications, stability protocols/reportsReview analytical method transfer/validation protocols, reports, and implementation plansAuthor and/or review APQRs, CTD sections of regulatory submissions, supplements, variations, and updates (e.g. BLA, IND, MAA, IMPD)Ensure critical reagents and reference standards are qualified and adequately supplied for clinical and commercial CMC programsMaintain compliant data integrity practices for document originated by CDMO/CTLsParticipate in supplier qualification audits, due diligence, and/or health authority inspections of CDMO/CTLsSupport product complaints, stock recovery/product recall, field alert and other quality events and regulatory actions as neededAuthor and/or review content of CDMO/CTL Quality AgreementsTravel approximately 10% of the time (domestic and international).Qualifications:
University degree in life sciences or related fields10+ years' experience in GMP Quality/QA/Quality Systems/ or Analytical Development in the biopharma/biologics/pharma industryExperience with data integrity assessments or remediation within an organization or at CMOs / CTOsHands-on experience in providing Analytical, QC or Microbiology support for clinical and commercial manufacturing, tech transfers, product launches and ongoing commercial suppliesKnowledge and expertise in principles and practices of cGMP for biologic drug substance, drug product and/or aseptic manufacturing experience is a plusExperience with CMO / CTO management (e.g. worked with or for CMOs / CTOs)Broad working knowledge of global regulations (i.e. ICH guidance, FDA/EMEA GMP regulations, etc.) for manufacturing, testing, packaging and distributing drug substances and drug productsDirect interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plusDemonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPAs at CMOs / CTOsExperience with assessing validation requirements for laboratory, facilities and equipmentThe ability to manage multiple priorities with aggressive timelines and changing priorities
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
This Jobot Job is hosted by: Katie GriffithAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $160,000 - $190,000 per year
A bit about us:
We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatment for patients.
Why join us?Competitive SalaryAnnual BonusEquity (RSUs)401k ProgramREMOTEHealth BenefitsCommercial DrugJob Details
We are looking for an Associate Director of Quality Operations who will provide laboratory QA support for our biologics commercial and clinical development programs by working closely with our various contract development and manufacturing organizations.
Our Quality Operations team consists of Lab QA, Manufacturing QA, and GMP/GDP Compliance functions. They are responsible for supporting all biologics CMC programs in compliance with our established procedures, cGMP, regulatory submissions, quality agreements, and other applicable guidelines and regulations.
Responsibilities:
Vendor management of contract laboratories. Facilitate routine external meetings, coordinate planning and delivery of testing results, lead implementation, and manage issue resolution.Review testing execution by CDMOs/CTLs, generate internal COAs, produce batch analysis and stability tables, and respond to emerging trend performance of drug substance and drug product across clinical and commercial CMC programsCapture records in Veeva for QMS activity at CDMO/CTLs, such as quality events, deviations, investigations, OOS/OOT, CAPA, Effectiveness checks, etc.Collaborate with Analytical Development group as needed, seeking additional technical support for test method implementation, troubleshooting, performance monitoring, and OOS/OOT investigationsDrive change management in Veeva for implementation and modification of Quality testing related lifecycle documents (i.e. test methods, specifications, stability protocols, and related technical documents)Design and lead new initiatives and process improvements to Laboratory QA processes, including business tools, escalation norms, communication piecesAuthor, review, or approve lifecycle documents governing the Laboratory QA function, including SOPs, analytical methods, specifications, stability protocols/reportsReview analytical method transfer/validation protocols, reports, and implementation plansAuthor and/or review APQRs, CTD sections of regulatory submissions, supplements, variations, and updates (e.g. BLA, IND, MAA, IMPD)Ensure critical reagents and reference standards are qualified and adequately supplied for clinical and commercial CMC programsMaintain compliant data integrity practices for document originated by CDMO/CTLsParticipate in supplier qualification audits, due diligence, and/or health authority inspections of CDMO/CTLsSupport product complaints, stock recovery/product recall, field alert and other quality events and regulatory actions as neededAuthor and/or review content of CDMO/CTL Quality AgreementsTravel approximately 10% of the time (domestic and international).Qualifications:
University degree in life sciences or related fields10+ years' experience in GMP Quality/QA/Quality Systems/ or Analytical Development in the biopharma/biologics/pharma industryExperience with data integrity assessments or remediation within an organization or at CMOs / CTOsHands-on experience in providing Analytical, QC or Microbiology support for clinical and commercial manufacturing, tech transfers, product launches and ongoing commercial suppliesKnowledge and expertise in principles and practices of cGMP for biologic drug substance, drug product and/or aseptic manufacturing experience is a plusExperience with CMO / CTO management (e.g. worked with or for CMOs / CTOs)Broad working knowledge of global regulations (i.e. ICH guidance, FDA/EMEA GMP regulations, etc.) for manufacturing, testing, packaging and distributing drug substances and drug productsDirect interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plusDemonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPAs at CMOs / CTOsExperience with assessing validation requirements for laboratory, facilities and equipmentThe ability to manage multiple priorities with aggressive timelines and changing priorities
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.