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 innovative anti-infective scientific pipeline and are committed to innovation, safety, and regulatory excellence.
The Opportunity
A pioneering innovator in infection prevention and combination antimicrobial solutions seeks a dynamic and proven Head of Quality to own and lead the Quality function at a fast-growing site in Petaluma, CA. This pivotal, hands-on leadership role is ideal for an experienced quality authority with success across pharmaceutical and medical device environments, ideally with combination product expertise.
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.
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