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Director of Quality Assurance

Jacobs Management Group, Inc.
San Antonio, TX Full Time
POSTED ON 1/14/2025
AVAILABLE BEFORE 4/6/2025

Are you ready to lead a team and make a tangible impact in women's healthcare? My client, a biopharmaceutical innovator, is dedicated to developing cutting-edge treatments addressing unmet medical needs, including endometriosis, fibroids, and hormone-dependent breast cancer. This role offers a chance to shape the quality systems of a growing organization transforming healthcare globally.

Why You Should Apply :

  • Be the cornerstone of quality assurance for a mission-driven company revolutionizing women's health.
  • Lead quality initiatives spanning preclinical, clinical, and commercial manufacturing programs.
  • Enjoy the chance to build and develop your own high-performing QA team.
  • Stay at the forefront of innovation, collaborating with top talent in drug development.
  • Competitive compensation with relocation assistance if applicable.

What You’ll Be Doing :

  • Overseeing company-wide quality assurance initiatives and ensuring regulatory compliance.
  • Developing and managing quality systems (e.g., eQMS) and creating / updating SOPs for GMP / GLP / GCP adherence.
  • Leading supplier qualification audits and managing the Supplier Quality Management Program.
  • Providing QA oversight for equipment qualification, facility commissioning, and software validation.
  • Representing the quality department during internal / external audits and regulatory inspections.
  • About You :

  • Be able to do the job as described.
  • Thrive in a leadership role, fostering growth and achievement within a team.
  • Expertise in FDA / EMA regulations and GMP / GLP / GCP practices.
  • Strong analytical skills for risk assessments, gap analysis, and root cause analysis.
  • Excellent technical writing and interpersonal communication abilities.
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