Quality Assurance Manager

Now Hiring: Quality Control Manager - Denver, CO

STAQ Pharma is looking for an experienced Quality Control (QC) Manager to join our growing team at our Denver, Colorado manufacturing facility. If you're passionate about sterile pharmaceutical production, microbiology, and building high-performing teams in a cGMP-regulated environment - this is your opportunity to lead and make an impact.

About STAQ Pharma

STAQ Pharma is a 503B Outsourcing Facility producing sterile injectable medications for adult and pediatric patients. Backed by a board comprised of large hospital systems, our mission is to deliver safe, timely, and high-quality medications. We're expanding and looking for exceptional professionals to help us build and grow.

What You'll Do

As the Quality Control Manager, you'll lead all QC operations at our Denver site, with direct responsibility for overseeing microbiology activities including environmental monitoring, trending, and sterility assurance. You'll drive compliance, team development, and data-driven improvements that align with STAQ's core values:

Safety, Transparency, Availability, and Quality.

Key Responsibilities:

Oversee microbiology activities and the execution of environmental monitoring across all classified areas of the facility.

Establish and manage a robust Environmental Monitoring Program using a risk-based approach.

Oversee QC processes to ensure compliance with FDA, USP, ICH, and cGMP (503B) standards.

Draft, review, and approve SOPs, protocols, reports, and QC-related documentation.

Lead investigations, CAPAs, deviations, and change controls related to microbiology and QC.

Serve as subject matter expert during audits and inspections related to microbiological control and testing.

Recruit, coach, and retain top talent to build and lead the QC and microbiology teams.

Manage the Stability Program, reserve samples, and sample submission to third-party labs.

Conduct viable/non-viable air, surface, and personnel environmental monitoring.

Track trends, analyze data, and implement continuous improvements for microbiological control.

Collaborate cross-functionally with Quality, Operations, and Regulatory teams.

Manage QC departmental budget and support business goals.

What You Bring

Education & Experience:

B.S. or B.A. in Microbiology or related scientific field (or equivalent experience).

5+ years of experience in quality control within a cGMP pharmaceutical or aseptic environment.

Proven experience overseeing microbiology operations and environmental monitoring programs.

Familiarity with FDA, USP, ICH, and 503B manufacturing regulations.

Preferred Skills:

Strong leadership, coaching, and decision-making skills.

Experience with 21 CFR Parts 11, 210, and 211.

Knowledge of aseptic techniques and cleanroom classifications.

Excellent communication and interpersonal skills with cross-functional collaboration.

Why STAQ?

Be part of a mission-driven organization focused on improving patient care.

Join a collaborative and inclusive culture that values your ideas and career growth.

Competitive salary, full benefits, and opportunities to make a lasting impact.

Ready to apply?

Permanent