Associate Director, Quality (Hands-On)

Associate Director, Quality (Hands-On)Location: Petaluma, CA (100% Onsite)Type: Contract-to-HireCompensation: $90–$120/hour (based on relevant experience)About the OpportunityWe are partnering with a fast-growing, pre-IPO pharmaceutical company developing innovative anti-infective technologies. With a major product launch approaching, the team is seeking a senior, hands-on Quality leader to help drive quality operations and build scalable systems in a fast-paced, evolving environment. This is a high-impact role with strong visibility across leadership and a clear path toward Director-level responsibility.What You'll DoOwn and lead the Quality function on-site, including QA systems, compliance, and executionDrive and oversee deviations, investigations, CAPAs, and root cause analysisSupport and influence product disposition decisions and risk assessmentsPartner cross-functionally with Manufacturing, R&D, and RegulatoryHelp build, improve, and scale QMS systems, SOPs, and documentationSupport audit readiness, regulatory inspections, and compliance effortsProvide hands-on QA support on the floor as neededOffer guidance and oversight on validation activities (IQ/OQ/PQ)What We're Looking For10–15+ years of experience in GMP-regulated environments (pharma, biotech, or combination products)Strong ownership of QMS systems (CAPA, deviations, change control)Experience supporting or making product disposition decisionsBackground in audit/inspection readiness and regulatory complianceDemonstrated ability to operate independently and make decisionsExperience working in fast-paced, evolving, or startup environmentsStrong collaboration and communication skills across technical teamsNice to HaveExperience with combination products (drug/device)Familiarity with FDA regulations (21 CFR 210/211 and/or 820)Exposure to biologics, cell/gene therapy, or CDMO environmentsExperience building or scaling quality systems from the ground upWhy This Role Stands OutPre-IPO company with strong equity upside potentialOpportunity to step into a high-visibility leadership roleDirect impact on product launch and company growthAbility to shape and build the Quality functionWhat to ExpectThis is a hands-on leadership role in a growing organization where processes are still being built and refined. The ideal candidate is someone who is comfortable stepping into ambiguity, solving problems quickly, and contributing both strategically and tactically.