JOB OBJECTIVE: The Sr. Director, Quality Assurance is responsible for the strategic development and execution of Usona’s quality assurance program including all quality-related decisions. This position reports to the Executive Director for the execution and administration of all GXP Quality Systems and is directly accountable for cGMP, GLP, GCP and GVP compliance in accordance with ICH, US, EU, and other relevant regulations. This position is expected to lead a team and collaborate across the organization on all quality matters and develop strong relationships with external consultants and contractors as necessary to support QA activities and responsibilities. The role requires expertise in current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practice (GVP) and relevant regulations across multiple jurisdictions. The successful candidate will drive, promote, and embed a culture of ethics, integrity, and continuous improvement focused on delivering efficiencies and maximizing Usona’s impact within its field of research.
1. Ensures that the Quality Management System meets standards expected by US and global regulatory authorities for research, development, and ultimately commercial activities.
2. Ensures quality metrics comply with best industry standards and practices.
3. Maintains effective quality governance and continually improves governance to meet organizational and compliance needs.
4. Accountable for overall quality and compliance oversight to include manufacturing, supply chain, nonclinical, and clinical functions.
5. 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 organizational quality standards and government regulations.
6. In collaboration with Clinical team, provides appropriate quality oversight of CROs.
7. Establishes, maintains, and leads oversight of internal Quality Management Systems. Continually evaluates and improves quality-related initiatives, priorities, and timelines.
8. Ensures that appropriate quality criteria are built into the selection/implementation of, and upgrades to, electronic systems used to support any GXP related activities.
9. Provides leadership and mentorship to the Quality team. Plans and oversees day-to-day activities of the Quality function including management of consultants/auditors as needed to ensure project and business needs are met.
10. Keeps abreast of industry developments, forthcoming regulations, guidance, best practices, etc.
11. Interprets and applies quality requirements and provides guidance and training to ensure that Usona and its GxP vendors maintain an ongoing state of compliance.
12. Communicates significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Usona’s Leadership Team.
13. Serves as an escalation point for organizational compliance and quality issues.
14. Serves as a primary contact in any audit by a regulatory authority and leads all audit communications with audit personnel from a regulatory agency. Responsible for supplier/vendor qualification audit and inspection management.
15. Conducts all duties in compliance with country-specific regulations, applicable SOPs, and other applicable guidelines.
16. Understands and complies with ethical, legal and regulatory requirements applicable to our business.
1. Bachelor’s degree, preferably in the life sciences.
2. 15+ years of relevant experience in GXP, QA leadership positions in a Biotech and/or Pharmaceutical industry.
3. Extensive knowledge and in-depth experience of implementation of Quality regulations in clinical, laboratory and pharmaceutical manufacturing environments for USA, EU and other global Health authorities.
4. Familiar with ICH Quality Guidelines and a demonstrated ability to utilize ICH Q9 / Quality Risk Management principles in everyday practice.
5. A hands-on leader with previous managerial experience who leads by example, inspires, and empowers team members.
6. Proactive in identifying opportunities with a strong solution-minded approach and flexibility to emerging challenges based on the scope and growth of the organization.
7. Strong collaborative, influencing, and interpersonal skills
8. Excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management.
9. Ability to prioritize competing activities, manage resources, and budget accordingly.
1. Master’s Degree
2. Experience/familiarity with regulations related to controlled substances
3. Proficiency with Microsoft Word, Excel, and Outlook.
1. Ability to use computer equipment.
Diversity is important at Usona. 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.