External QA Manager - Permanent - New York City
Are you passionate about quality and precision? Join our pharmaceutical client and help ensure top-tier standards every day with this position in Supplier Quality.
The External Quality Manager is responsible for overseeing supplier quality and quality control activities related to the company's product portfolio.
Primary Responsibilities:
This role supports the Quality leadership team and plays a key part in maintaining and enhancing the company's quality management system. A successful candidate will partner with new and existing suppliers and CMOs to ensure their manufacturing practices, environments, and quality systems align with regulatory expectations and internal standards. The role also serves as an administrator for the company's QMS and performs audits to ensure GMP compliance. Additionally, this individual reviews production and quality documentation, batch records, and supports product release activities.
Skills & Requirements:
- Bachelor's or Master's degree in a scientific discipline is preferred
- 7-12 years of Quality Assurance experience in pharmaceuticals, OTC, or medical devices.
- Strong knowledge of global GMP and ISO standards
- Experience in auditing and qualifying suppliers and CMOs.
The External QA Manager's responsibilities will be:
- Oversee supplier and CMO compliance with GMP and quality system requirements.
- Review and approve batch records, quality documentation, and product release packages.
- Conduct quality and compliance audits of external partners.
- Lead investigations, root cause analyses, and CAPA implementation.
- Support continuous improvement initiatives and inspection readiness activities.
- Act as administrator for the electronic Quality Management System (QMS).
- Willingness to travel up to 25%
Compensation:
- $120,000 to $160,000 per annum.
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
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