Director of Quality Assurance

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.