What are the responsibilities and job description for the Director of Pharmaceutical Quality Assurance position at Amneal Pharmaceuticals?
About the Role:
As a seasoned professional in quality assurance and regulatory compliance, you will lead the strategic direction of our pharmaceutical operations. Your expertise will be instrumental in ensuring compliance with global standards and regulations.
Key Responsibilities:
Requirements:
As a seasoned professional in quality assurance and regulatory compliance, you will lead the strategic direction of our pharmaceutical operations. Your expertise will be instrumental in ensuring compliance with global standards and regulations.
Key Responsibilities:
- Manage quality assurance processes for drug-device combination products globally
- Drive the Quality digital strategy and coordinate digital initiatives across U.S. plants
- Serve as the key interface with the FDA, vendors, and partners for dispute resolution and compliance communications
- Oversee the management of product recalls, ensuring compliance with regulatory standards and efficient communication across teams
- Determine, follow up, and close Field Alert Reporting (FAR) processes to ensure timely resolution of issues
- Oversee quality operations for external manufacturing in Europe and America, ensuring compliance with global standards
- Support international product submissions and commercialization by coordinating regulatory document availability for partners
Requirements:
- Bachelors Degree (BA/BS) Life Sciences, Engineering, or related field - Required
- Master Degree (MS/MA) Advanced degree - Preferred
- Must have a minimum 20 years of experience in quality assurance and regulatory compliance within the pharmaceutical industry, with significant experience in drug-device combination products
- Skills: Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), EU, DEA, OSHA and other pertinent compliance organizations and regulations and global regulatory requirements.
