Quality Assurance Manager

2 weeks ago


Berkeley Heights, New Jersey, United States Breckenridge Pharmaceutical Inc Full time
Position Overview

Breckenridge Pharmaceutical Inc. is dedicated to the development and marketing of high-quality, value-added, and cost-efficient generic medications in the United States. Our products are innovatively developed within our own research and development facilities and through strategic collaborations with manufacturers globally.

This role reports directly to the Associate Vice President of Quality Assurance and encompasses the management and support of various critical functions: ensuring compliance with current Good Manufacturing Practices (cGMP) for contract manufacturers, overseeing the company's Standard Operating Procedures (SOP) and Training systems, administering the QA/QC Testing and Audit program, and making Quality and Compliance decisions related to the Company's Abbreviated New Drug Application (ANDA) products, as well as those adhering to Over-the-Counter (OTC) Monographs and FDA or other industry-recognized standards for Dietary Supplements and Medical Foods.

Key Responsibilities:

  • Conduct, support, and assess third-party audits of existing and prospective vendors for cGMP compliance.
  • Oversee the SOP system, which includes drafting, revising, and maintaining SOPs, along with managing SOP Tracking and Training.
  • Facilitate the market distribution of product batches.
  • Manage the review and resolution of batch deviations, Out-of-Specification (OOS) reports, and proposed Corrective and Preventative Actions (CAPAs) from manufacturers for Dietary Supplements and Medical Foods.
  • Address product quality complaints effectively.
  • Assist with FDA audits and inspections of the company or its manufacturing partners as necessary.
  • Conduct Product Quality Reviews, including the evaluation of manufacturers' annual product review reports.
  • Oversee change control reviews for Dietary Supplements and Medical Foods products.
  • Review batch records as required.

Essential Qualifications, Education, and Experience:

  • Bachelor's degree required (preferably in a technical or scientific field such as biology, chemistry, pharmacy, or another relevant science/technology).
  • A minimum of 7 years of experience in the pharmaceutical sector, with a focus on Quality Assurance and Quality Systems (preferably with at least 2 years in a management role within QA).
  • Willingness to travel domestically to contract manufacturing sites, with potential for international travel for audits.


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