Director, Quality Compliance
Skills
- In-depth knowledge of FDA, EMA, ICH quality regulatory standards
- Expertise in risk management, CAPA, product complaints, and change control
- Experience with electronic Quality Management Systems and Computer System Validation (CSV)
- Strong leadership and project management skills
- Excellent communication skills for diverse stakeholder engagement
Responsibilities
- Maintain an inspection-ready Quality Management System (QMS) compliant with global standards.
- Oversee electronic Quality Management System (eQMS) validation, data integrity, and compliance.
- Manage documentation and training records aligned with regulatory requirements.
- Lead the development and implementation of GxP training programs.
- Support quality metrics development and risk management processes.
- Direct Change Control, Product Quality Review, and complaint investigation programs.
- Oversee Computer System Validation complying with 21 CFR Part 11 and EU Annex 11.
- Collaborate with Medical Affairs, Regulatory, and IT for quality compliance governance.
Education
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or related field
Benefits
- Competitive compensation with annual performance bonus
- Hybrid work model with 2 days remote per week
- Comprehensive medical, dental, vision, and prescription plans
- 401(k) retirement plan with up to 5% company match
- Generous vacation policy with rollover and sick/wellness days
- Company holidays including extra week off at year-end
- Tuition reimbursement for professional growth
- Azurity High Five peer recognition program
- Bagel Tuesday on-site perk
Average salary estimate
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Azurity specializes in providing innovative, high-quality medicines that serve overlooked patients. We supply a large number of products to treat a wide range of medical conditions. These include cardiovascular, central nervous system, endocrine, ...
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