What are the responsibilities and job description for the Director of Quality Assurance position at Jacobs Management Group, Inc.?
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.
