Quality Manager

Quality Manager (Path to Director)

Location: Petaluma, CA (100% onsite)

Type: Contract-to-Hire (3–6 months before conversion to direct)

Industry: Pharmaceutical / Combination Products

Overview

We are partnering with a rapidly growing, pre-IPO pharmaceutical company developing next-generation anti-infective technologies. They are preparing for a near-term product launch and are building out their Quality organization.

This role is a hands-on Quality leadership position with a clear path to Director. The ideal candidate will be someone who can personally execute quality work while also taking ownership of the QA function in a fast-paced, startup environment.

Key Responsibilities

• Own and execute Quality Assurance activities across the organization
• Support product launch readiness, ensuring compliance with GMP and regulatory requirements
• Develop and implement quality systems (SOPs, CAPAs, deviations, documentation)
• Lead root cause investigations and drive corrective/preventive actions
• Ensure compliance with FDA regulations, ISO 13485, and combination product requirements
• Support audits, inspections, and regulatory readiness
• Collaborate cross-functionally with R&D, Manufacturing, and Regulatory teams
• Evaluate and qualify vendors, including those without established quality systems
• Operate independently with minimal oversight in a startup environment
  
  

Must-Have Qualifications

• 5–10 years of experience in GMP-regulated environments (pharma preferred)
• Strong hands-on experience with:
• CAPA, deviations, investigations
• Quality systems implementation
• GMP compliance (21 CFR 210/211 and/or 820)
• Experience supporting or leading product development and/or commercialization
• Demonstrated ability to solve complex quality problems independently
• Comfortable working in fast-paced, unstructured or startup environments
• Strong communication and cross-functional collaboration skills
  

Compensation

• Hourly Range: $55-$65/hr.
• Contract period before conversion (3–6 months typical)
• Significant equity opportunity (pre-IPO)
  
  

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About Kelly

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