Senior Director, Clinical Quality Assurance Job at EPM Scientific, Princeton, NJ

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  • EPM Scientific
  • Princeton, NJ

Job Description

Senior Director of Quality Assurance (GCP) - Drive Excellence in Cutting-Edge Oncology Innovation!

Backed by $500 MILLION in Funding | Transforming Oncology Treatments | A Culture of Innovation & Impact

Are you a Quality Assurance leader passionate about revolutionizing oncology therapies? This is your chance to join a high-growth, well-funded biotech that is redefining cancer treatment through groundbreaking multispecific antibody and cell therapy advancements.

With $500+ million in funding, this powerhouse is scaling rapidly and pushing the boundaries of scientific innovation. You'll be at the forefront of clinical quality strategy, ensuring compliance with global GCP regulations while shaping the future of cutting-edge oncology trials.

Why You'll Love It Here:

  • A mission-driven company dedicated to transforming patient outcomes.
  • Elite scientific minds collaborating to drive real-world impact.
  • A fast-paced, high-growth environment where your work directly shapes the future of medicine.
  • Unparalleled career growth as the company expands its clinical and regulatory footprint.

Your Role:
As the Senior Director of Quality Assurance (GCP), you'll be the architect of excellence, leading quality oversight for global clinical trials and ensuring best-in-class compliance with GCP regulations. If you thrive in high-energy biotech settings and are eager to make a meaningful impact, this is the place to be.

Join a biotech revolution fueled by innovation, vision, and half a billion+ dollars in funding!

Desired Skills and Experience

Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
SME in GCP guidelines, ICH-GCP, FDA regulations, and other relevant regulatory requirements.
Experience conducting GCP audits, inspections, and vendor qualifications/assessments.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across departments and with external stakeholders.
Detail-oriented mindset with a proactive approach to problem-solving and decision-making.
Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.

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