Clinical research quality manager

Castle Biosciences, Inc.
Pittsburgh, PA

Castle Biosciences Earns a Top Workplaces USA Award for the Fourth Consecutive Year!

You won't find a work culture and benefits package like ours every day. Come join our team and a group of colleagues who love working at Castle!

Learn more at

Castle Biosciences Inc. **is growing, and we are looking to hire a Clinical Research Quality Manager working remotely from your home office based in the USA.

Why Castle Biosciences?**

  • Exceptional Benefits Package:
  • Excellent Annual Salary + 20% Bonus Potential
  • 20 Accrued PTO Days Annually
  • 10 Paid Holidays
  • 401K with 100% Company Match up to 6%
  • 3 Health Care Plan Options + Company HSA Contribution
  • Company Stock Grant Upon Hire

A DAY IN THE LIFE OF A Clinical Research Quality Manager

The Quality Manager provides oversight of quality assurance activities for the Clinical Research department at Castle Biosciences, Inc. (CSTL). This role includes leading, under the direction of the Associate Director, the development, implementation, and maintenance of the quality management system, as well as managing the clinical research audit program. Key responsibilities include assisting with internal and external audits, reviewing audit reports, analyzing findings for trends, and reporting recommendations to leadership. The Quality Manager also oversees corrective and preventative actions, supports department training in collaboration with subject matter experts, and ensures standard operating procedures align with regulatory requirements. Additional duties include preparing the department for FDA and other regulatory inspections, assisting in drafting responses to findings, identifying compliance risks, and driving continuous process improvements.

REQUIREMENTS

  • Bachelor's degree in related field (preferred) or demonstrated experience as evidence of competency
  • Minimum of 3 years of clinical research experience required
  • Minimum of 1 year of experience managing direct reports required
  • Working knowledge of U.S., European and/or global regulations and standards covering clinical research
  • In some cases, an equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered

*Please see the full success profile at the end of the job ad.

TRAVEL

  • Occasional travel, up to 10%, may be required for this position to support site internal audit activities and staff training opportunities

SCHEDULE

  • Monday - Friday, 40/hrs. per week, exempt position, working remotely from your home office based in the USA.

READY TO JOIN OUR BIOTECH TEAM?

We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon!

ABOUT CASTLE BIOSCIENCES INC.

At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes.

Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding . We behave with integrity and treat our colleagues with respect and kindness . Our culture fosters an environment of trust, transparency, and collaboration . We prioritize and encourage internal growth and professional development .

Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals withdisabilities.

If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail [email protected] .

This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response.

** No third-party recruiters, please

Posted 2025-10-06

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