Job Description

We have a current opportunity for a Crystal Pharmatech - Director of QA on a permanent basis. You'll be the face of Quality during client and regulatory inspections, help shape regulatory strategy across sites, and build a culture of excellence by mentoring and growing the QA team.

This is a great fit for someone with 10+ years of QA leadership experience in a CRO or biotech setting who thrives in a collaborative, fast-moving environment.

This is a high-impact leadership role, reporting into the CEO, where you'll drive the development and continuous improvement of GLP and GCLP quality systems supporting both nonclinical and clinical testing.

• Must have hands-on GLP QA experience in a CRO or Biotech/Pharma setting
• Experience in GLP/GcLP, Bioanalysis.
• Experience leading regulatory and client inspections
• Will oversee Quality Systems, SOPs, and Compliance
• Salary Range $150,000.00 - $200,000.00 per year
  

Desired Skills and Experience

Acting as the face of Quality during client and regulatory inspections, help shape regulatory strategy across sites build a culture of excellence by mentoring, and growing the QA team. This is a great fit for someone with 10+ years of QA leadership experience in a CRO or biotech setting who thrives in a collaborative, fast-moving environment.

-Extensive GLP/GCLP expertise with a deep understanding of regulatory requirements (FDA, OECD, ICH) in a bioanalytical lab or CRO environment

-Proven leadership in Quality Assurance, including hosting audits, managing inspection readiness, and overseeing SOPs, training, and risk documentation

-Strong cross-functional collaboration and communication skills, with the ability to influence senior leadership and drive quality initiatives across multiple sites

-Strategic thinking and regulatory insight to proactively identify compliance risks and implement scalable, forward-thinking quality systems

Job Tags

Permanent employment,

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