Director of Quality (GLP/GCLP) Job at EPM Scientific, Pleasanton, CA

ZFZJajZnMmp5Q0FBdWlySDhiTitOVVRCV2c9PQ==
  • EPM Scientific
  • Pleasanton, CA

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,

Similar Jobs

Yale New Haven Health

Certified Child Life Specialist Job at Yale New Haven Health

 ...normal living patterns and minimizing psychological upset. As integral members of the interdisciplinary health care team, child life specialists provide children opportunities for gaining a sense of mastery, for play, for learning, for self-expression, for family involvement... 

ContactLink Solutions LLC

Dari Freelance US-Based VRI/OPI Interpreter Job at ContactLink Solutions LLC

LANGUAGE: Dari US-Based VRI/OPI Interpreter As a remote interpreter, you play a significant role in facilitating communication between DARI and English speakers. The interpreter needs to be able to process information quickly and with accuracy in a professional manner...

Children's National Hospital

Nursing Manager Job at Children's National Hospital

 ...cardiac surgeons, cardiologists, pediatric intensivists, and nursing in conjunction with multiple specialty services within the hospital...  ...cardiac team with all sub-specialists readily available and accessible. The unit-based staff includes a dedicated pharmacist,... 

Aquent Studios

Freelance Photographer Job at Aquent Studios

 ...Aquent is currently looking to build a team of highly professional, freelance corporate photographers interested and available for projects with a global brand. We are looking for candidates that have the flexibility to be called on for photography projects on an "as needed... 

Odyssey Agency

Freelance Writer Job at Odyssey Agency

About Odyssey Growth Group: Odyssey helps 7-9-figure consumer brands increase revenue, ROAS, and high-fives. With our unique understanding of messaging, targeting, media channels, and creative, we help companies find the inflection point that unlocks their next stage...