Job Details

Kelly Science & Clinical is seeking a Head of Quality for a contract-to-hire opportunity with an innovative biotechnology and medical device company in Petaluma, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology and medical device industries.

Workplace: Onsite in Petaluma, CA.

Position Title: Head of Quality

Position Type: Contract-to-hire

Pay rate: $65-85 per hour.

Company: Kelly Science & Clinical

Client Overview:

Our client is a leader in developing and manufacturing advanced antimicrobial technologies for medical and consumer applications. They specialize in an innovative anti-infective scientific pipeline and are committed to innovation, safety, and regulatory excellence.

About the Role

We are seeking an accomplished Head of Quality to lead our end-to-end Quality organization across drug, device, and combination product development and manufacturing. This leader will own the full Quality function—including QA, QC, Microbiology, Validation, and Regulatory Quality interface. This role requires a hands-on, execution-oriented leader capable of building, scaling, and continuously improving a GMP-compliant Quality Management System (QMS) in a fast-moving, resource-constrained environment.

Key Responsibilities

• Lead the Quality function end-to-end, spanning QA, QC, Microbiology, Validation, and Quality Regulatory interactions.
• Serve as the Quality authority during FDA inspections, audits, and regulatory submissions
• Set the Quality vision, strategy, and roadmap aligned with patient safety, compliance, and business objectives.
• Stand up, remediate, and scale a full GMP-compliant QMS suitable for drug, device, and combination product operations.
• Update, create, and harmonize procedures to meet QMSR, ISO 13485, and 21 CFR 210/211 requirements.
• Oversee investigations, deviations, CAPAs, and change controls to ensure thorough, timely, and compliant resolution.
• Manage supplier quality, auditing, and qualification.
• Provide oversight of batch release, validation (IQ/OQ/PQ), stability, environmental monitoring, and other Quality operations.

Qualifications

Required

• Proven Head of Quality (or equivalent) experience, with direct ownership of the full Quality function
• Experience in both pharma and medical devices, ideally including combination product development or commercialization.
• Strong experience supporting or leading operations governed by FDA drug and device regulations.
• FDA facing authority with firsthand experience leading FDA inspections and acting as the accountable Quality representative.
• Demonstrated success building, remediating, or scaling a GMP compliant QMS.
• Deep technical Quality expertise: Investigations, CAPAs, change management, risk analysis, validation, supplier quality, and product release.
• Proven ability to lead teams, set expectations, and drive accountability without micromanaging.
• Ability to make autonomous, risk-based Quality decisions in a fast-paced environment.
• Strong written and verbal communication skills, including influencing skills at the executive level.

Preferred

• Experience in early-stage or growth-stage startups.
• Prior ownership of combination product Quality systems.
• Experience transitioning or integrating systems to meet QMSR requirements.

Why Join?

• Direct Impact: Shape the future of breakthrough antimicrobial technologies and drive global impact.
• True Leadership: Be the authority for all things Quality—100% end-to-end ownership.
• Growth & Challenge: Join a values-driven, mission-centric team shaping the next generation of infection prevention solutions.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.