Associate Director, PV Quality
1 day ago
h2JobSummary/h2pWeareseekingahighlyskilledAssociateDirector,PVQualitytoprovidequalityoversightof,andsupportandguidancetotheModernapharmacovigilancesystemandpharmacovigilanceactivitiesconductedbyModernaanditsserviceproviders./ppTheidealcandidatewillhaveastrongbackgroundinqualityassurance,pharmacovigilance,andregulatorycompliance,withexperienceinleadingteamsanddevelopingqualitystrategies./ph3KeyResponsibilities/h3ulliProvidequalityoversightoftheModernapharmacovigilancesystemandpharmacovigilanceactivitiesconductedbyModernaanditsserviceproviders./liliSupportandguidethedevelopmentofqualitystrategiesandpoliciesforthepharmacovigilancefunction./liliLeadthedevelopmentofPVAnnualAuditPlansandconductauditsofModerna'sPharmacovigilanceSystem./liliCollaboratewiththeGlobalPharmacovigilanceandR&DQuality&Compliance(RDQ&C)ProcessExcellenceandTrainingteamstosupportthedevelopmentofR&DpoliciesandproceduresrelatedtoPVactivities./liliPartnercloselywithmembersoftheGlobalPharmacovigilanceandtheQPPVtosupportthesuccessfulandcompliantexecutionofModernaPVactivities./li/ulh3Requirements/h3ulliBS/BA,MSorPhD/PharmDandaminimumof10,8,6yearsexperience,respectively,inBiotech,PharmaorClinicalResearchOrganization./liliAuditcertification(e.g.,ASQLeadAuditor)preferred./liliStrongknowledgeofrelevantglobalguidelinesandapplicableGVPregulations,guidelinesandlocallegislation./liliKnowledgeofrelevantFDA,EU,guidanceforcomputerizedsystemsisaplus./liliExperienceworkingwithCROs,vendors,andrelationshipmanagement./liliStronginterpersonalskillsandabilitytointeracteffectivelywithalllevelswithintheorganization./liliLeadershipskillstoprovidetraining,mentoring,andmanagingqualityprofessionals./li/ulh3WhatWeOffer/h3pModernaoffersacomprehensiveandinnovativesuiteofbenefits,includinghighlycompetitiveandinclusivemedical,dentalandvisioncoverageoptions,flexiblespendingaccounts,lifestylespendingaccountfunds,familycarebenefits,andmore./ppWeareproudtobeanequalopportunityworkplaceandareanaffirmativeactionemployer.Modernaiscommittedtoequalemploymentopportunityandnon-discriminationforallemployeesandqualifiedapplicantswithoutregardtoaperson'srace,color,sex,genderidentityorexpression,age,religion,nationalorigin,ancestryorcitizenship,ethnicity,disability,militaryorprotectedveteranstatus,geneticinformation,sexualorientation,maritalorfamilialstatus,oranyotherpersonalcharacteristicprotectedunderapplicablelaw./p
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Associate Director, PV Quality
5 hours ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking a highly skilled Associate Director, PV Quality to join our team. The successful candidate will provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.The Associate Director, PV Quality will lead the development of...
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Associate Director, PV Quality
3 days ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced Associate Director, PV Quality to provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers. The successful candidate will provide compliance support to the Moderna PV organization, establish and...
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Associate Director, PV Quality Management
5 days ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced Associate Director, PV Quality to join our team. This role will provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.Key ResponsibilitiesProvide compliance support to the Moderna PV...
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Associate Director, PV Quality
4 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced Associate Director, PV Quality to provide quality oversight of our pharmacovigilance system and support the development of quality and compliance strategies for global pharmacovigilance activities.Key ResponsibilitiesDevelop and implement quality and compliance strategies for pharmacovigilance activitiesConduct audits...
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Director, PV Regulatory
3 weeks ago
Cambridge, Massachusetts, United States ONO PHARMA USA Full timeJob SummaryONO PHARMA USA is seeking a highly experienced and skilled Director, PV Regulatory to lead our Pharmacovigilance (PV) Regulatory Affairs function. The successful candidate will be responsible for ensuring compliance with regulatory requirements, developing and implementing PV strategies, and providing expert guidance to cross-functional teams.Key...
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Director, PV Regulatory Affairs
2 weeks ago
Cambridge, Massachusetts, United States ONO PHARMA USA Full timeJob SummaryWe are seeking a highly experienced and skilled Director, PV Regulatory Affairs to join our team at ONO PHARMA USA. The successful candidate will be responsible for leading our Pharmacovigilance (PV) Regulatory Affairs function, ensuring compliance with regulatory requirements and developing strategies to enhance our PV capabilities.Key...
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Associate Director, PV Quality Management
2 weeks ago
Cambridge, Massachusetts, United States BioSpace, Inc. Full timeJob SummaryWe are seeking an experienced Associate Director to lead our Pharmacovigilance Quality team. The successful candidate will provide quality oversight and support to our pharmacovigilance system and activities, ensuring compliance with global regulations and guidelines.Key ResponsibilitiesDevelop and implement quality strategies to ensure compliance...
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Associate Director, Quality Operations
2 weeks ago
Cambridge, Massachusetts, United States US Tech Solutions Full timeJob Title: Associate Director, Quality OperationsUS Tech Solutions is seeking an experienced Associate Director, Quality Operations to join our team. In this role, you will be responsible for ensuring the quality and compliance of our commercial drug distribution operations.Key Responsibilities:Manage third-party logistics service provider operations...
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Cambridge, Massachusetts, United States ONO PHARMA USA Full timeJob SummaryWe are seeking a highly experienced Director of Pharmacovigilance Regulatory Affairs to lead our PV Regulatory Affairs function. The successful candidate will be responsible for developing and implementing PV strategies, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to drive business growth.Key...
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Clinical Quality Director
4 weeks ago
Cambridge, Massachusetts, United States Alkeus Pharmaceuticals, Inc. Full timeAbout Alkeus Pharmaceuticals:We are a late-stage biopharmaceutical company dedicated to developing innovative therapeutics for serious eye diseases. Our lead compound, gildeuretinol (ALK-001), is an oral investigational drug being developed for the treatment of Stargardt disease and Geographic Atrophy secondary to dry age-related macular degeneration. For...
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Cambridge, Massachusetts, United States Foghorn Therapeutics Full timeJob Title: Associate Director, Analytical Development and Quality ControlFoghorn Therapeutics is seeking an experienced Associate Director to lead our Analytical Development and Quality Control functions. As a key member of our team, you will be responsible for driving the development and validation of analytical methods, ensuring the successful advancement...
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Director of Quality Operations
4 days ago
Cambridge, Massachusetts, United States Meet Full timeJob Title: Associate Director, Quality OperationsJob Summary:We are seeking an experienced Associate Director, Quality Operations to oversee commercial product distribution and maintain Good Distribution Practices (GDP) for our US affiliate. This role will manage third-party logistics providers, handle product release for distribution, and ensure compliance...
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Cambridge, Massachusetts, United States Third Rock Ventures Full timeSenior Manager/Associate Director, Quality ControlThird Rock Ventures is seeking a Senior Manager/Associate Director, Quality Control to lead and independently perform technical and operational aspects of QC activities for antibody and fusion protein products across the company's pipeline. The ideal candidate will have a strong background in analytical...
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Senior Director of Quality Control
5 days ago
Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full timeJob Title: Senior Director, Quality ControlBeam Therapeutics Inc. is seeking a highly experienced Senior Director of Quality Control to join our team in Cambridge, Massachusetts.Job Summary:The Senior Director of Quality Control will be responsible for leading the quality control organization at Beam's Massachusetts facility. This role will oversee the QC...
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Director of Quality Operations
23 hours ago
Cambridge, Massachusetts, United States Meet Full timeJob Title: Director of Quality OperationsSummary:The Director of Quality Operations is responsible for overseeing commercial product distribution and maintaining Good Distribution Practices (GDP) for the US affiliate. This role manages third-party logistics providers, handles product release for distribution, and ensures compliance with GDP regulations and...
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Cambridge, Massachusetts, United States Flagship Ventures Full timeJob Title: Associate Director/Director, Precision OncologyFlagship Pioneering's venture creation engine has conceived and created companies such as Moderna Therapeutics (NASDAQ: MRNA), Sana Biotechnology (NASDAQ: SANA), Generate Biomedicines, and Tessera Therapeutics. We are seeking a talented and highly motivated Associate Director/Director Oncology to play...
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Senior Director of Quality Assurance
3 days ago
Cambridge, Massachusetts, United States Jobot Full timeJob Title: Senior Director, Quality AssurancePublicly Traded + Equity + Annual Bonus + HybridWe are a publicly traded biotechnology company developing biologics to treat chronic dermatological diseases.Why Choose Us?Competitive SalaryAnnual BonusEquityESPP401k ProgramMedical/Vision/DentalHybrid ScheduleJob Description:We are seeking a Senior Director of...
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Director, Drug Safety and Pharmacovigilance
4 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Director, Drug Safety and PharmacovigilanceJob Summary:Bicycle Therapeutics is seeking a highly experienced Director, Drug Safety and Pharmacovigilance to lead the clinical safety activities for assigned compounds within the organization. The successful candidate will be responsible for the implementation, execution, and management of...
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Associate Director of Biostatistics
3 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Associate Director, BiostatisticsBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking an experienced Associate Director of Biostatistics to join our Biometrics team.Job SummaryThe Associate Director of Biostatistics will be responsible for leading biostatistical...
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Associate Director of Biostatistics
4 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Title: Associate Director, BiostatisticsBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking an experienced Associate Director of Biostatistics to join our Biometrics team.Job SummaryThe Associate Director of Biostatistics will be responsible for leading biostatistical...