Job Description

Job Title: Manager, Quality Assurance

Location: New Jersey (On-site)

Position Summary:

We are looking for an experienced and knowledgeable Quality Assurance Manager to lead and support a range of quality-related activities. This includes ensuring cGMP compliance, managing SOP and training systems, overseeing QA/QC testing procedures, and making quality and compliance decisions for a diverse range of products, including generic pharmaceuticals, dietary supplements, and medical foods.

Key Responsibilities:

• Conduct and support third-party audits of current and proposed vendors to assess cGMP compliance.
• Manage and maintain the SOP system, including drafting, revising, tracking, and training on SOPs.
• Oversee market distribution activities for product batches.
• Review and resolve batch deviations, Out-of-Specification (OOS) reports, and proposed Corrective and Preventative Actions (CAPAs) from manufacturers related to Dietary Supplements and Medical Foods.
• Handle product quality complaints and implement resolutions.
• Support regulatory audits and inspections, including those conducted by the FDA, for the organization and its manufacturing partners.
• Conduct Product Quality Reviews, including evaluating manufacturers' annual product review reports.
• Manage change control processes for Dietary Supplements and Medical Foods.
• Perform batch record reviews as required.

Qualifications and Experience:

• Bachelor’s degree in a technical or scientific discipline (e.g., biology, chemistry, pharmacy, or related field).
• Minimum of 7 years of experience in the pharmaceutical industry, with a focus on Quality Assurance and Quality Systems.
• At least 2 years of experience in a management role within QA is preferred.
• Strong understanding of cGMP compliance and quality standards for pharmaceutical products.
• Willingness to travel domestically to contract manufacturing sites, with potential international travel for audits.

Job Tags

Similar Jobs