Job Information
PROMEGA CORPORATION Director Quality Assurance in MADISON, Wisconsin
JOB REQUIREMENTS: Job Description JOB OBJECTIVE: The Director, Quality Assurance (QA), is responsible for leading and executing Usona\'s comprehensive quality assurance program. This includes overseeing all quality-related decisions, ensuring full compliance with GCP, GLP, GMP, and GVP standards, and supporting Usona\'s commitment to excellence in research and drug development. The Director plays a pivotal role in the oversight of clinical study quality assurance, ensuring adherence to regulatory requirements and promoting the integrity of clinical trial data. This position ensures the continuous improvement of the Quality Management System, driving efficiencies and innovations to maximize Usona\'s impact in its field of research and development. By fostering a culture of compliance, ethics, and forward-thinking, the Director contributes to Usona\'s mission while maintaining strong relationships with internal and external stakeholders. CORE DUTIES: 1. Ensures that the Usona Quality Management System meets standards expected by US and global regulatory authorities for research, development, and commercial activities. 2. This role will oversee the development of training programs that foster a growth mindset and continuous learning among quality staff. 3. Leads leadership development opportunities within the quality team to ensure alignment with the organization\'s emphasis on personal and professional growth. 4. Ensures that quality metrics comply with best industry standards and practices. 5. Maintains effective quality governance and continually improves governance to meet organizational and compliance 6. Accountable for overall quality and compliance oversight to include clinical, non-clinical, manufacturing, and supply chain functions. 7. Establishes strong working relationships with external product manufacturers and assures alignment of Quality Management Systems and requirements with these CMOs. Ensures that products manufactured at CMOs meet regulations, guidelines, and Usona requirements. 8. In collaboration with the Clinical team, ensures robust quality oversight of Contract Research Organizations (CROs) and clinical study-related activities including site selections and qualification, while maintaining compliance with GCP standards. 9. Oversees QA aspects of clinical trial conduct, including protocol adherence, data integrity, and participant safety across all phases of clinical studies. 10. Ensure the QMS actively supports cross-departmental communication and collaboration, particularly with regulatory, clinical, and manufacturing teams. 11. Establishes, maintains, and leads oversight of the internal Usona... For full info follow application link. Diversity is important at Promega. We are proud to be an Equal Opportunity Employer, and make employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/D5DC6A989EEB4E2C Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.
