Quality Manager

Quality Manager


Job ID: 10159200

Petaluma, CA, US

Engineering

High School or equivalent

Full Time, Temp to Hire

$55-$65/hr.

Manager (Manager/Supervisor)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Petaluma, CA, US

$55-$65/hr.

Manager (Manager/Supervisor)

Full Time, Temp to Hire

Biotechnology/Pharmaceuticals

On-site

Engineering

High School or equivalent

First Shift (Day)

Job details

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)

10159200

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