Associate Director of Global Quality

I’m excited to announce that I am partnered with an innovative and rapidly growing biotechnology company seeking an Associate Director, Global Quality.

This is a newly created leadership role driven by significant company growth, an expanding product portfolio, and ambitious manufacturing timelines. The position reports directly to the SVP of Quality Assurance & Regulatory Affairs and will serve as a key partner in scaling both external and internal manufacturing quality operations.

The organization is entering a transformative phase, including the build-out of a new manufacturing facility and the transfer of multiple products into commercial manufacturing over the next several years, making this an exciting time to join.

The preferred location is Menlo Park, CA (hybrid), though exceptional candidates outside California will be considered. Hybrid arrangements are preferred, but remote may be possible for outstanding talent.

What they're looking for:

• 10+ years of Pharmaceutical GMP Quality Assurance experience

• Strong manufacturing quality experience (highly preferred)

• Experience with batch review, batch release, deviation investigations, CAPA management, validation, and technology transfer

• Experience building, implementing, and maintaining Quality Management Systems (QMS)

• Leadership experience through direct management or demonstrated ability to lead cross-functional teams

• Experience with MasterControl, TrackWise, or similar quality systems preferred

• Controlled substance manufacturing experience is a plus

• Small molecule and biologics experience are both welcome

• Bachelor's degree required; industry experience is valued more heavily than academic credentials

What this role offers:

Impact: Play a key role in shaping the quality strategy and manufacturing infrastructure of a rapidly growing biotech.

Growth: Help build and scale a quality organization that will continue to expand significantly over the coming years.

Visibility: Partner directly with senior leadership and influence critical business and manufacturing decisions.

Challenge: Lead both external manufacturing oversight and future internal manufacturing quality initiatives.

Travel: Approximately 25–33%, including visits to manufacturing sites in US, Europe, and external partners.

The team is actively interviewing. If this could be of interest to you—or someone in your network—please feel free to reach out directly or submit your resume for consideration.