Top Tech Jobs & Startup Jobs in Denver & Boulder, CO

The Sr. Director, GMP Quality Assurance oversees GMP quality assurance for products, leads teams, develops strategies, and ensures compliance with regulations, promoting patient safety and quality culture.

Lead administration and enhancement of enterprise applications with primary ownership of NetSuite. Provide hands‑on support, manage integrations, ensure compliance (SOX, FDA 21 CFR Part 11), gather requirements, drive implementations, and deliver training to support Supply Chain, Finance, HR, Procurement, and Quality processes in a regulated biotech environment.

The Principal CMC Statistician drives statistical strategies for biopharmaceutical processes, ensuring regulatory compliance and optimizing manufacturing through robust data analysis and collaboration with scientific teams.

Perform and review QC microbiology testing and environmental monitoring for lentiviral vector manufacturing. Support method establishment, equipment qualification, microbial investigations, document generation, training delivery, sample shipping, and continuous improvement in a cGMP-regulated QC laboratory.

Support downstream manufacturing operations, focusing on purification processes and compliance with GMP. Execute buffer preparation, chromatography, and material management while adhering to quality systems and SOPs.

The Senior Specialist in Quality Assurance will manage vendor QA oversight, GMP supplier processes, and support GxP operations within the Quality Assurance team.

Lead and manage cross-functional projects in supply chain and manufacturing, ensuring timely execution and adherence to quality standards while collaborating with internal and external stakeholders.