Fractional Head of Quality / Sterile Manufacturing Startup

Fractional Head of Quality / Sterile Manufacturing StartupScottsdale, Arizona | Fractional / Contract | On-site during key phasesOpen to equity participation for the right personWe’re building a sterile manufacturing operation in Scottsdale focused on lyophilized peptide products.This is an early-stage build. We are making real decisions around facility design, cleanroom strategy, equipment, SOPs, quality systems, and startup execution right now.We are looking for a Fractional Head of Quality / Sterile Manufacturing Startup to help us build it the right way from day one.This is not a role for someone who wants to sit in meetings, write vague SOPs, and act important. We want someone who has actually been in the trenches of aseptic manufacturing, fill-finish, lyophilization, validation, and quality systems and knows how to turn a startup facility into a controlled, disciplined operation.If you like building from scratch, solving problems early, and preventing expensive mistakes before they happen, keep reading.What you’ll doYou’ll help lead the buildout of the quality and sterile manufacturing foundation for the business, including:Building the core quality system from the ground upDrafting and implementing SOPs, batch records, forms, logs, and release workflowsHelping shape facility layout, material flow, personnel flow, gowning, and contamination control strategyAdvising on modular cleanroom design and sterile workflow decisionsSupporting equipment selection, startup, qualification, and operational readiness for filling and lyophilizationEstablishing practical systems for deviations, CAPA, change control, investigations, training, and document controlHelping define environmental monitoring, cleaning, sanitation, and maintenance programsSupporting IQ/OQ/PQ, process qualification, and general validation readinessPutting real guardrails in place so products do not move forward unless they meet defined standardsWorking closely with the founder on hiring priorities, consultant selection, vendor qualification, and startup sequencingWhat we actually needWe do not need a corporate QA person who only knows how to protect themselves with paperwork.We need someone who can look at a startup manufacturing plan and say:what is missingwhat is wrongwhat is overbuiltwhat is undercontrolledwhat needs to happen firstwhat can waitand how to build it into something realYou should be comfortable going from high-level strategy to nitty-gritty execution.Ideal background8+ years in sterile manufacturing, aseptic processing, fill-finish, and/or lyophilizationDirect experience standing up, scaling, remediating, or running sterile operationsStrong command of cGMP quality systems in a sterile environmentExperience writing and implementing SOPs, batch records, investigations, CAPAs, and training systemsExperience with equipment qualification, process readiness, and validation planningStrong understanding of contamination control, cleanroom behavior, and sterile operator disciplineAble to operate in a founder-led environment without needing layers of bureaucracyBig plus if you haveExperience with lyophilized vial productsExperience commissioning freeze dryers or sterile filling equipmentExperience with peptides, injectables, biologics, or other sensitive sterile productsExperience helping evaluate lower-cost imported equipment without losing control of qualityStartup or small-company experience where you had to actually build, not just manageNot a fit ifYour background is mostly document administration without real sterile manufacturing depthYou like advising but not implementingYou need a large team and a big budget before you can get movingWhat success looks likeWe avoid dumb facility and equipment mistakes earlyThe quality system is practical and usable, not bloatedThe operation has real sterile discipline from the beginningLeadership gets a clear roadmap for what needs to be built now vs laterWe end up with a scalable manufacturing foundation, not a fragile science projectEngagement structureWe expect this to start as a fractional / contract role and grow from there if it makes sense.Likely range: 10–25 hours per week to start, with heavier involvement during key design, qualification, and startup phases.We are also open to structuring the right long-term relationship for the right person, including the potential for an equity partnership if there is strong alignment, deep relevant experience, and a meaningful desire to help build this business over time.This is not a fully remote role. We need meaningful involvement in Scottsdale, especially when facility, equipment, workflow, and implementation decisions are being made.How to applySend over:your resume or LinkedIna short note on your sterile manufacturing and lyophilization experienceexamples of facilities or operations you helped stand up, fix, or scaleyour availability and preferred structureIf you’ve actually built sterile operations and know how to bring order to startup chaos, we’d like to talk