We are a rapidly growing generic pharmaceutical company focused on providing high-quality, affordable healthcare solutions. With a strong global supply chain and a commitment to excellence, we are dedicated to improving patient care.
Key Responsibilities:
- Develop and manage the compliance program, ensuring adherence to regulatory standards.
- Stay updated on regulatory changes and implement necessary program updates.
- Conduct audits of manufacturing units and vendors to meet FDA and DEA requirements.
- Collaborate with various departments to enhance quality compliance processes.
- Create and deliver compliance training for all employees.
- Investigate compliance issues and recommend corrective actions.
- Maintain a database of FDA observations to educate staff on best practices.
Key Skills:
- Strong background in Quality Assurance, with a focus on compliance evaluation.
- Experience with cGMP and regulatory audits.
- Proficiency in TrackWise IS A MUST - Microsoft Office Suite (Word, Excel, PowerPoint).
- Knowledge of federal DEA regulations and compliance oversight.
Qualifcations:
- Bachelor’s degree in Biology, Chemistry, Biochemistry, Pharmacy, or a related field.
- 8+ years in compliance oversight within a cGMP-regulated environment.
- Strong understanding of domestic and international cGMP regulations.
- Proven ability to lead small to medium-sized teams and address compliance issues effectively.
