Associate Director, Quality Compliance

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.

About the Role

• Oversee Quality Compliance team of @ 4 including Managers/ Sr. Executives to maintain a robust, inspection-ready Quality Management System (QMS) in a regulated pharmaceutical environment, ensuring compliance and addressing high-risk areas through key performance indicators. This role ensures integrity, compliance, and continuous improvement of controlled electronic documents, learning, and quality system records with a strong focus on GxP and regulatory requirements, including 21 CFR Part 11 and EU Annex 11.

Key Responsibilities

• Lead implementation and compliance with quality metrics and KPIs to monitor performance.
• Lead quality risk-management meetings and escalate issues to senior management.
• Identify improvement opportunities and implement fixes in quality systems and processes.
• Lead the change-control process and ensure compliance with quality metrics.
• Lead the CAPA system and ensure compliance with quality metrics.
• Lead the Product Quality Review process and ensure compliance with quality metrics.
• Lead the Computer System Validation program and ensure compliance with 21 CFR Part 11 and EU Annex 11.
• Maintain an efficient, inspection-ready Quality System.
• Lead data integrity through validated electronic systems.
• Support the electronic Document Management System.
• Ensure procedures are issued, reviewed, and approved by appropriate personnel.
• Maintain training records and quality documentation per regulatory requirements
• Enable training for staff involved in GxP activities.

Required Skills and Experience

• Lead effectively—motivate teams, take productive positions on key issues, and mentor staff.
• Train and guide staff in quality compliance, interpreting regulatory compliance concepts and identifying issues with proactive, creative, and risk-mitigating solutions.
• Communicate clearly in writing and verbally to both technical and non-technical audiences and write/edit quality documents effectively.
• Collaborate effectively across global teams.
• Demonstrate independent thought, strong negotiation skills, integrity, and adaptability.
• Work independently and in virtual environments.
• Demonstrate strong MS Office skills, including Excel, PowerPoint, and MS Project

Preferred Qualifications

• Prefer a Bachelor and/ or Masters in a scientific discipline with 10+ years of Quality Assurance/ Compliance experience.
• Demonstrate proven success in leading a team in managing quality systems including document management, learning management, quality systems record management, and computer system validation.
• Possess FDA, EU, Canada, and/ or ROW inspection experience with solid GxP, FDA, and EU regulatory knowledge.
• Demonstrate proven success in leading and preparing teams for self -inspections and health-authority inspections (e.g., FDA, HPRA, HC, Swiss medic etc.)
• Prefer experience managing CMOs and CLOs.
• Have prior management experience supervising entry- to mid-level quality professionals.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.