What are the responsibilities and job description for the Senior Manager of Global Compliance position at Amneal Pharmaceuticals?
About Amneal Pharmaceuticals:
We are an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Job Description:
As a member of our team, you will be responsible for guiding the team in Computer System Validation (CSV) efforts, ensuring compliance with CFR Part 11 and effective risk management. You will also oversee the management of product recalls, ensuring compliance with regulatory standards and efficient communication across teams.
Responsibilities:
We are an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Job Description:
As a member of our team, you will be responsible for guiding the team in Computer System Validation (CSV) efforts, ensuring compliance with CFR Part 11 and effective risk management. You will also oversee the management of product recalls, ensuring compliance with regulatory standards and efficient communication across teams.
Responsibilities:
- Guide the team in Computer System Validation (CSV) efforts, ensuring compliance with CFR Part 11 and effective risk management
- Ensure compliance at the R&D facility located in Piscataway, NJ
- Review and harmonize global quality standards to ensure alignment across all regions
- Collaborate with partners and Contract Manufacturing Organizations (CMOs) to address audit findings and improve compliance
