Job Details

Associate Director, Quality (Hands-On)

Location: Petaluma, CA (100% Onsite)

Type: Contract-to-Hire

Compensation: $90–$120/hour (based on relevant experience)

About the Opportunity

We 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 Do

• Own and lead the Quality function on-site, including QA systems, compliance, and execution
• Drive and oversee deviations, investigations, CAPAs, and root cause analysis
• Support and influence product disposition decisions and risk assessments
• Partner cross-functionally with Manufacturing, R&D, and Regulatory
• Help build, improve, and scale QMS systems, SOPs, and documentation
• Support audit readiness, regulatory inspections, and compliance efforts
• Provide hands-on QA support on the floor as needed
• Offer guidance and oversight on validation activities (IQ/OQ/PQ)

What We're Looking For

• 10–15+ 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 decisions
• Background in audit/inspection readiness and regulatory compliance
• Demonstrated ability to operate independently and make decisions
• Experience working in fast-paced, evolving, or startup environments
• Strong collaboration and communication skills across technical teams

Nice to Have

• Experience with combination products (drug/device)
• Familiarity with FDA regulations (21 CFR 210/211 and/or 820)
• Exposure to biologics, cell/gene therapy, or CDMO environments
• Experience building or scaling quality systems from the ground up

Why This Role Stands Out

• Pre-IPO company with strong equity upside potential
• Opportunity to step into a high-visibility leadership role
• Direct impact on product launch and company growth
• Ability to shape and build the Quality function

What to Expect

• This 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.