Job Description
Description:
The VP, Corporate Quality will lead the strategic oversight of product recalls, compliance, and validation processes across multiple global sites. This role will involve collaboration with manufacturing, engineering, and regulatory teams to ensure that quality standards and regulatory requirements are met, particularly for drug-device combination products and external manufacturing operations.
Essential Functions:
- 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
Additional Responsibilities:
- Guide the team in Computer System Validation (CSV) efforts, ensuring compliance with CFR Part 11 and effective risk management
- Ensure the annual filing of the CARES Act reporting requirements related to drug manufacturing for commercial distribution in the U.S
- Provide statistical analysis support to all sites to inform quality decision-making processes
- 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
- Develop and manage a global AI approach to enhance quality operations and issue management
- Assess current and changing regulations, identifying gaps and evolving strategies to ensure compliance
Qualifications
Education:
- Bachelors Degree (BA/BS) Life Sciences, Engineering, or related field - Required
- Master Degree (MS/MA) Advanced degree - Preferred
Experience:
- 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. - Mastery
- Proven track record in managing complex quality operations and compliance programs - Mastery
- Excellent analytical and problem-solving abilities - Mastery
- Strong leadership and team management skills - Mastery
- Effective communication and interpersonal skills, with the ability to interface with diverse stakeholders - Mastery
- Experience with digital transformation and Artificial Intelligence (AI) initiatives in quality processes - Advanced
About Us
Amneal is 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.
