Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company’s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.
Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.
Brief Team/department Description
Azurity Pharmaceuticals is seeking a Director of Quality, Standards & Training to lead drug safety quality systems, standards, audits, and training activities within the Global Drug Safety organization. This role is integral in ensuring compliance, leadership oversight and maintaining inspection readiness, supporting compliance with global pharmacovigilance (PV) regulations, and enabling consistent execution of drug safety processes through effective documentation and training.
Reporting to the
Vice President, Global Drug Safety, this director level role will work closely with Drug Safety Operations, Compliance, Quality, and cross-functional partners to lead SOP management, training coordination, and continuous improvement initiatives.
Principle Responsibilities
- Lead the global drug safety quality and training strategy, ensuring compliance with regulatory authority requirements.
- Design, implement and oversee a reisk-based Quality Management System (QMS) for drug safety including SOP governance, deviation management, CAPAs, inspection readiness and audit support.
- Develop and maintain a comprehensive drug safety framework including onboarding, role-based curricula, annual compliance training and vendor/partner training oversight.
- Drive inspection readiness and audit excellence serve as the Drug Safety Quality lead during internal audits, partner audits and regulatory inspections.
- Establish KPIs and quality metrics to monitor compliance.
- Partner cross-functionally with teams to ensure alignment of safety processes, and training adherence.
- Lead and develop a high performing Quality & Training Team, fostering a culture of accountability, continuous improvement and operational excellence withing drug safety.
Qualifications And Education Requirements
- 10 years of experience in pharmacovigilance, quality, compliance, training, or related roles within pharmaceutical, biotech, or regulated healthcare environments.
- Leadership experience and oversight of drug safety compliance, CAPAS, Deviations and change controls.
- Advanced understanding of global regulations and experience leading audits.
