GMP Facility Launch Director

Summary

Our client, a pharmaceutical sterilization technology company focused on providing proprietary sterilization technology to the pharmaceutical and medical device industries, has engaged GForce Life Sciences to provide a Director, GMP Facility Launch & Operational Readiness consultant. This position will report to the CEO. This individual will lead enterprise-level execution of critical site launch will own the cross-functional execution of facility readiness, qualification, operational launch, and customer onboarding for a new contract sterilization operation.

Duties / Expectations of Rol

eThe Director, GMP Facility Launch& Operational Readinesswill lead enterprise-level execution of a critical site launch program spanning

• :Facility completion and GMP readines
• sEquipment installation and qualification (IQ/OQ/PQ
• )Quality system implementatio
• nOperational readiness and staffin
• gBatch record finalization and release system
• sCustomer validation suppor
• tMock runs and operational simulatio
• nCommercial go-liveexecutio

n
Key Responsibilities/Executive Program Leadersh

• ipServe as the executive program leader for launch of a new contract sterilization operatio
• n.Own the integrated operational readiness strategy and execution plan through commercial go-liv
• e.Develop and maintainthe master programschedule aligned to an operational laun
• chLead cross-functional governance acros
• s:Quality & Regulato
• ryValidation & ProcessEngineeri
• ngOperatio
• nsTechnical/Lab Suppo
• rtFacilities & E
• HSCommercial &Customer Onboardi
• ngEstablish executive reporting, KPIs, risk dashboards, and escalation mechanism
• s.Drive accountability for milestone execution and resolve cross-functional conflicts rapidl

y.
Facility & Technical Readin

essEnsure facility readinessfor regulated contractsterilization operations, includi

• ng:Material and personnel f
• lowProduct segregat
• ionEnvironmental readin
• essSafety systems and gas handling contr
• olsLead coordination of equipment installation, commissioning, and qualification activiti
• es.Oversee completion
• of:Installation Qualification (
• IQ)Operational Qualification (
• OQ)Performance Qualification (
• PQ)Ensure cycle control systems, calibration, maintenance, and operational controls are fully implemented before lau

nch
Quality & Compliance Leader

shipPartner with Quality leadership to ensure an audit-ready operational framework aligned w

• ith:ISO 1
• 4937ISO 1
• 3485GMP expectations for pharmaceutical and medical device custo
• mersOversee implementation and readiness
• of:Core QMS proced
• uresBatch record sys
• temsDeviation/CAPAprog
• ramsChange con
• trolDocument con
• trolTraining sys
• temsEnsure internal audit readiness prior to go-l

ive.
Operational Readiness & Launch Exec

utionDirect development of operational systems required for launch, inclu

• ding:Material intake and chain-of-cu
• stodyScheduling and capacity pla
• nningOperator training and qualific
• ationBatch execution work
• flowsRelease pat
• hwaysLead mock batch execution and full end-to-end operational simulat
• ions.Require and overseemultiple “stress test” scenarios, including intentional deviations and fa

iluremodes, to validate systemrobustness before la

• unch.Lead controlled commercial ramp during the first 60–90 days post-la

unch.
Customer & Commercial Rea

dinessEnsure readiness for regulated customer onboarding incl

• uding:Statements of Work
• (SOWs)Quality agre
• ementsValidation support pa
• thwaysCustomer
• auditsTechnical transfer requir
• ementsSupport onboarding of initial strategic customers and first validation pro

grams.
Customer & Commercial Re

adinessOwn enterprise risk identification and mitigati

• on for:Schedule
• delaysValidation bott
• lenecksDocumentat
• iongapsQuality readiness f
• ailuresStaffing re
• adinessCustomer onboardin
• g risksDrive critical earlydecisions inc
• luding:Release model strategy (parametric vs BI
• -based)Internal vs outsourced laboratory
• supportCapacity and staffin
• g modelProduct/customer prioritization s

trategy
Mandatory Requ

• irementsBachelor’s degree in Engineering, Pharmaceutical Sciences, Life Sciences, Manufactu

ring, orrelated discipline; advanced degree pr

• eferred.15 years of leadership experience in pharmaceutical, biologics, medical device, sterilization, or highly regulated manufacturing envir

onments.Demonstrated success

• leading:GMP manufacturing facility s
• tart-upsMajor facilitybuild-outs or operational
• launchesCross-functional readiness
• programsEquipment commissioning and qualification ini
• tiativesStrong working knowl
• edge of:IQ/OQ/PQ e
• xecutionGMP manufacturing
• systemsValidation
• strategyBatch record e
• xecutionOperational readiness
• planningRegulatory inspection r
• eadinessProven ability to lead highlycross-functional teams in deadline-driven envir

onments.
Term &a

• mp; Start10 month contract with conversion to p
• ermanent.S
• tart ASAPFull time (40 ho
• urs/week)100% onsite in Greater Balt
• imore, MDBenefits included (Medical, Dental, Visi