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.