Director, Quality Compliance
2 days ago
Highlight
OnsiteFull-timeDirector
Summary
Azurity Pharmaceuticals is seeking a Director, Quality Compliance to join their team in Woburn, MA. The role involves ensuring the organization maintains an inspection-ready, compliant, and efficient Quality System that supports all GxP-related activities.
About the Role
As the Director of Quality Compliance, you will oversee the electronic Quality Management System (eQMS), documentation management, data integrity, and compliance infrastructure. Your responsibilities include maintaining a robust Quality Management System, managing documentation and training records, leading GxP training programs, supporting quality metrics development, and facilitating Quality Risk Management processes. You will also oversee Change Control processes and manage Product Quality Review and Complaint programs.
About You
Required:
- Bachelor's or Master’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
- Minimum of 10 years of experience in quality assurance, with at least 5 years in a leadership role within a GxP-regulated environment.
- In-depth knowledge of global regulatory standards (FDA, EMA, ICH, etc.) for quality systems.
- Strong expertise in risk management, product complaints, change control, and Computer System Validation (CSV).
- Proven ability to communicate complex compliance topics clearly to stakeholders at all levels.
- Excellent leadership, project management, and problem-solving skills.
Benefits
- Competitive compensation package, including an annual bonus based on company performance.
- Comprehensive health coverage including medical, dental, vision, and prescription.
- Hybrid work model allowing two days from home and three days in the office.
- 401K retirement savings plan with dollar-for-dollar matching up to 5%.
- Generous time off policy with up to 15 vacation days annually and five sick/wellness days.
- Tuition reimbursement for undergraduate and graduate level courses or certifications.
- Recognition platform for celebrating colleagues' accomplishments.
Azurity Pharmaceuticals
Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of patients with underserved conditions. 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.
Woburn, MA