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 Youll 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.