Quality Manager
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)
- CAPA, deviations, investigations
- 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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