Associate Director, Early Development Quality (R&D QA)

Overview

TheEarlyDevelopmentQualityLeadisresponsibleforthestrategicqualityoversightofinternalandexternal(outsourced)activitiesinsupportofnonclinicalstudies(GLPandnon-GLP),INDenablingwork,aswellastheutilizationofBiomarkerswithindevelopmentprograms(preclinicalandclinical).

ThisrolewillpartnerwithAlnylamcolleagueswithinEarlyDevelopment,Bioanalytical,NonclinicalWriting,Research,andClinicalResearchtoprovidequalitysupportandoversightandensuretheidentification,mitigation,andescalationofemergingqualityrisksandconcerns.

ThispositionwillbelocatedwithintheUSandcanbe hybrid,onsite,orremote.

KeyResponsibilities

• Setsthestrategicqualityoversightdirectionforinternalandoutsourcedlaboratoryactivitiessupportingnonclinicalstudies(GLPandnon-GLP),includingtoxicology,bioanalyticalandbiomarkerdatathatsupportsINDsubmissions.
• EstablishandmaintainqualityoversightofexternallaboratoriesincludingTestFacilities,TestSites,andClinicalLaboratoriesbyimplementinggovernanceframeworkandongoingperformancemonitoring.
• Collaboratewithnonclinicalandclinicalteams(inpartnershipwithGCPProgramLeads)tointegratequalityconsiderationsintotheselection,contracting,andmanagementofexternallabs.
• Ensureinternallydevelopedandoutsourcedbiomarkerdevelopment / analyticalworkcomplieswithinternalqualitysystemrequirementsandexternalregulatorystandardsincludingGCP,GLP,ICH,andOECD.
• Refineandcontinuouslyimplementrobust,risk-basedvendoroversightandauditprogramgloballyfornonclinicalwork.LeadtheriskassessmentandauditstrategyforexternallaboratoriesandensureplannedauditsareexecutedinalignmentwiththeGCP / GLPyearlyauditprogram.
• Supportthemanagementofnonclinicalandclinicallabfocusedqualityissuesarisingfromoutsourcedactivities,includingqualityevents,significantqualityissues,andCAPAoversight.
• ServesastheQualityescalationpointforCRO / vendorqualityissuesandleadsqualitygovernanceactivitiestoensureappropriateidentification,issueescalationandthemitigationofemergingcompliancerisks.
• ProvidesqualitystrategicdirectionforthefunctionalevaluationofCROorkeyvendorprocessesorprocessimprovementopportunities.
• DrivethestrategicidentificationandimplementationofprocessimprovementopportunitieswithinAlnylam'sQMS,insupportofearlydevelopmentandresearch.
• PartnerswithLegal / Procurementforappropriateoversightlanguageincontractualagreementsandensurecompliance

Qualifications

U.S. Pay Range

$161,000.00 - $217,800.00

The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on a number of factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus or sales incentive) and an annual long-term incentive award (e.g., equity).

Alnylam's robust Total Rewards package is designed to support your overall health and well-being. We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match. Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks. We also offer generous family resources and leave. Our commitment to your well-being reflects our belief that caring for our people fuels the impact we create together.

Learn more about these and additional benefits offered by Alnylam by visiting the Benefits section of the Careers website : https : / / www.alnylam.com / careers

AboutAlnylam

We are the leader in RNAi therapeutics- a revolutionaryapproach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possibleand are just at the beginning of what's possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values : fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, wherean authentic, inclusive culture and breakthrough thinkingfuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.