Director of Quality Compliance
2 weeks ago
About Us:
Amneal Pharmaceuticals is a leading pharmaceutical company seeking a highly skilled Director of Quality Compliance to join our team.
Job Summary:
This role will oversee core facility compliance functions, ensuring adherence to regulatory requirements and industry standards. The ideal candidate will have a strong background in quality assurance, auditing, and compliance, with excellent leadership and communication skills.
Responsibilities:
* Provide management oversight for internal manufacturing and laboratory investigations (planned and unplanned)
* Conduct customer complaint investigations and perform risk assessments
* Develop and implement corrective actions to mitigate compliance risks
* Inform senior management of potential issues impacting site compliance
Requirements:
* Bachelor's degree in a scientific discipline (e.g., chemistry, biology, pharmacy) - Required
* 3+ years of experience in the pharmaceutical industry, with supervisory experience
* Strong knowledge of cGMP and FDA regulations, particularly 21 CFR part 210 and 211
* Excellent written and oral communication skills; technical writing ability; organizational skills; supervisory skills
Salary: $120,000 - $150,000 per year
Benefits:
Amneal Pharmaceuticals offers a competitive benefits package, including health insurance, retirement plan, and paid time off.
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