Quality Director

Pharmaceutical Lab Director (Petaluma, CA)

QA Director needed for Product Pharmaceutical Compliance, Full-Time, On-Site Location: Petaluma, CA Reports To: Chief Operating Officer / CEO.

This position will start as a Quality Consultant role managing the main lab, then, move to a permanent Quality Director with very equitable stock options- the company will go public in less than 12 months- This role is a fantastic opportunity to establish yourself for huge earnings in under two years.  Worried about medical benefits while consulting? Don’t worry- we got you! As a Kelly Engineering Consultant (estimate will be about 60-100 days), we have many medical plans and other perks available for you.

Role Overview:

Seeking an experienced QA Lab Director (From Pharma) to lead Quality Assurance department and drive compliance for combination products and pharmaceutical regulations. This role is critical to ensuring readiness for our upcoming product launch in April and establishing a robust quality infrastructure for future growth.  Lab Director will build and scale the quality team, implement GMP-compliant systems, and serve as the primary authority on regulatory compliance for both drug and device components. The right person will have ownership of the entire QA function (at the org level) not team level, and need experience acting as a final QA decision maker, QA department ownership and exec level inspection experience.

Key Responsibilities:

Lead Quality Department- Establish and manage the QA function, including hiring and mentoring quality staff.

Regulatory Compliance- Ensure adherence to GMP, FDA, ISO 13485, and combination product regulations.

Product Launch Readiness- Oversee quality activities to meet aggressive timelines for April launch.

Quality Systems Development- Design and implement SOPs, validation protocols, and documentation systems.

Audit Inspection Management- Prepare for and lead internal audits, FDA inspections, and ISO certifications.

Risk CAPA Oversight- Drive root cause analysis, CAPA programs, and continuous improvement initiatives.

Cross-Functional Collaboration- Partner with R D, manufacturing, and regulatory teams to align quality objectives with business goals.

Qualifications:

Ownership of the entire QA function (at the org level) not team level, experience acting as a final QA decision maker, QA department ownership and exec level inspection experience.

8-10 years of experience in a GMP-regulated environment, with strong pharmaceutical background combination product experience a plus.

Proven leadership in building and scaling quality teams.

Deep knowledge of FDA regulations, ISO standards, and drug/device compliance requirements.

Strategic thinker with hands-on execution ability in a fast-paced, startup-like environment.

Strong communicator who can influence decisions and advocate for compliance.

Understanding of the following fundamentals: QMSR, for a device-led combination products, the 5 pharma requirements from (210/211) that need to be incorporated into the streamlined quality system to meet the Combination Product requirement, deviations and non-conformances, and understanding the difference, R&D components for commercial production, even if “research only,”  and, finally, managing vendors, even ones with no formal quality system.

Bachelor s degree in Life Sciences, Engineering, or related field advanced degree preferred . Certification in Quality e.g., CQE, Six Sigma is a plus.

Experience/willingness to learn deeply- combination products and device regulations.

8-10 years or plus relevant experience, pharma preferred, the right person with medical devices may also be considered.

Company Overview:

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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