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Quality Manager
Petaluma, CA, US
Engineering
Bachelors Degree
Full Time, Temp to Hire
$65.00 to $75.00 per hour**
Manager (Manager/Supervisor)
On-site
Biotechnology/Pharmaceuticals
First Shift (Day)
Petaluma, CA, US
$65.00 to $75.00 per hour**
Manager (Manager/Supervisor)
Full Time, Temp to Hire
Biotechnology/Pharmaceuticals
On-site
Engineering
Bachelors Degree
First Shift (Day)
Job details
Quality Manager (Petaluma, CA)
Kelly Engineering has an outstanding opportunity for a contract to hire QA Manager role with an organization that is committed to advancing solutions for some of the most challenging issues in healthcare in Petaluma, CA. The QA Manager will lead our Quality Assurance department and drive compliance for pharmaceutical and combination product regulations. You’ll be critical for our major product launch and key to building robust quality processes for future growth.
You will be working with innovative technologies to improve outcomes across a wide range of medical applications, from patient care settings to medical product development. With substantial growth ahead and an upcoming public offering, this is an exceptional opportunity to join a dynamic company offering significant equity potential.
Key Responsibilities:
Build, scale and manage the QA team; hire and mentor quality staff.
Ensure regulatory compliance with GMP, FDA, ISO13485 and combination product requirements.
Oversee launch readiness and quality activities to meet urgent product timelines.
Develop and implement SOPs, validation protocols, and quality documentation systems.
Lead audit and inspection preparation.
Drive root cause analysis, CAPA programs, and continuous improvement.
Engage with R&D, manufacturing, and regulatory teams to align quality and business goals
What We Are Looking For:
8+ years of Quality leadership experience in a pharmaceutical environment (combination product experience a plus).
Expertise in FDA regulations, ISO standards, drug/device compliance.
Demonstrated ability to build and scale high-performing quality teams.
BS/MS in a related discipline.
Our client is pioneering advanced anti-infective chemistries to combat some of the most challenging issues in global healthcare. Their proprietary platforms are designed to eradicate infectious agents including antibiotic-resistant strains across a wide range of applications, from surgical sites and wound care to medical devices and inhalation therapies.
Currently they are developing a non-toxic alternative to antibiotics, aiming to revolutionize infectious disease treatment. With plans to go public next year, this is an opportunity to join a high-growth company offering significant equity potential.
Significant equity opportunities with plans to go public next year. This role is not only a chance to lead quality operations for an innovative pharmaceutical platform on the brink of product launch, it’s also a unique wealth-building opportunity. By joining at this critical pre-IPO stage, you will earn substantial equity—once the company’s pioneering therapies succeed and the IPO is successful, your stock options could rapidly multiply in value, leading to potential life-changing financial rewards- in less than two years! For those looking to turn deep expertise into real ownership—and to help shape a next-generation pharma leadership, this is a rare and compelling opportunity not to miss.
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