Promega Jobs

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. Ensure robust implementation and monitoring of GCP compliance frameworks to maintain operational integrity across clinical studies. 9. Oversees QA aspects of clinical trial conduct, including protocol adherence, data integrity, and participant safety across all phases of clinical studies. Directs the development of processes to systematically audit and review clinical trials, ensuring alignment with FDA and EMA regulatory requirements. 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 Quality Management System including Clinical trials, CAPA, Vendor management GMP and GCP. Continually evaluates and improves quality-related initiatives, priorities, and timelines. 12. Ensures that appropriate quality criteria are built into electronic systems that are used to support any GxP related activities. Emphasizes GCP-related quality systems, ensuring rigorous compliance with global standards during all phases of clinical trials. 13. Provides leadership and mentorship to the Quality team. Plans and oversees day-to-day activities of the Quality function including management of QA staff and consultants as needed to ensure that project and business needs are met. The role of quality in cross-functional meetings to guide in resolving potential bottlenecks, ensuring alignment with the broader drug development strategy and timelines. 14. Responsible for ensuring quality oversight includes pharmacovigilance infrastructure for safety monitoring and reporting. Oversees the integration of GCP-compliant processes within pharmacovigilance systems to ensure participant safety and data integrity. 15. Works in close collaboration with the Director of Regulatory Affairs to ensure timely submissions and compliance with evolving global regulatory requirements. 16. Keeps abreast of industry developments, forthcoming regulations, guidance, and best practices. 17. Interprets quality requirements and provides guidance to ensure that Usona maintains an ongoing state of compliance. 18. Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to the Usona Leadership Team. 19. Serves as an escalation point for organizational compliance and quality issues. 20. Serves as the primary contact during regulatory inspections and leads all audit communications with inspection personnel from a regulatory agency. 21. Demonstrates a genuine curiosity and enthusiasm for leveraging AI technologies to enhance efficiency, improve processes, and drive innovation within your role. Willingness to learn and adapt to new AI tools is essential. Collaborate with AI tools for real-time quality monitoring. Including utilization of AI for predictive analytics to anticipate potential quality risks or compliance gaps. 22. Demonstrates inclusion through words and actions and is accountable for a safe workspace. Acts with kindness, curiosity, and respect for others. 23. Embraces and incorporates Promega's Emotional & Social Intelligence (ESI) core principles in daily work. 24. Understands and complies with ethical, legal, and regulatory requirements applicable to our business. 25. Designs and implements comprehensive GCP- related training programs to enhance team competence and awareness across clinical teams and external partners. KEY QUALIFICATIONS: 1. Bachelor's degree, preferably in the life sciences or equivalent education and experience. 2. 12+ years of relevant hands-on experience in GxP, QA leadership positions in the Biotech and/or pharmaceutical industry. 3. Extensive, hands-on knowledge of GCP principles, including experience in developing, managing, and auditing clinical quality systems for trials. Proven track record of ensuring compliance with FDA, EMA, and other regulatory authorities. 4. Extensive knowledge and hands-on experience implementing Quality regulations, with a strong emphasis on GCP, in clinical, laboratory, and pharmaceutical manufacturing environments for US, EU, and other global Health authorities. 5. Familiar with ICH Quality Guidelines and a demonstrated ability to utilize ICH Q9 / Quality Risk Management principles in everyday practice. 6. A collaborative, hands-on leader with proven experience fostering a culture of teamwork and inclusion, inspiring and empowering team members to achieve both individual and organizational goals. 7. Proactive in identifying opportunities for process optimization with a strong solution-minded approach and flexibility to emerging challenges based on the scope and growth of the organization. 8. Strong collaborative, influencing, and interpersonal skills. 9. Excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management. 10. Ability to prioritize competing activities, manage resources, and budget accordingly. PREFERRED QUALIFICATIONS: 1. Master's Degree, preferably in the life sciences. 2. Experience in designing and delivering GCP-related training programs and compliance initiatives for clinical and operational teams. 3. Experience and familiarity with regulations and guidelines related to controlled substances. 4. Proficiency with Microsoft Word, Excel, and Outlook. PHYSICAL DEMANDS: 1. Ability to use computer equipment and move within clinical, laboratory, and production environments during inspections and audits. At Usona, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.