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Quality Assurance Manager

2 months 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 within the United States. Our products are innovatively crafted in our in-house R&D facilities and through strategic collaborations with manufacturers globally.

This role reports directly to the Associate Vice President of Quality Assurance and encompasses the management or support of: cGMP compliance evaluations of contract manufacturers, oversight of the company's Standard Operating Procedures (SOP) and Training systems, QA/QC Testing/Audit programs, and Quality/Compliance decisions pertinent to the Company's ANDA products, as well as products adhering to OTC Monographs and FDA or other recognized industry standards for Dietary Supplements and Medical Foods.

Key Responsibilities:

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

Essential Qualifications, Education, and Experience:

  • Bachelor's degree required (preferably in a technical/science 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/Quality Systems (preferably at least 2 years in a QA management capacity).
  • Willingness to travel domestically to contract manufacturing sites, with potential for international travel for audits.