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Quality Assurance Manager
2 months ago
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 crafted in-house through our R&D facilities and in collaboration with global manufacturing partners.
This role reports directly to the Associate Vice President of Quality Assurance and encompasses the management and support of various critical functions: ensuring cGMP compliance for contract manufacturers, overseeing the company's Standard Operating Procedures (SOP) and Training systems, managing the QA/QC Testing and Audit program, and making Quality/Compliance decisions pertaining to the Company's ANDA products, as well as those governed by OTC Monographs and FDA or other recognized standards for Dietary Supplements and Medical Foods.
Key Responsibilities:
- Conduct, support, and assess third-party audits of current and prospective vendors for cGMP compliance.
- Oversee the SOP system, which includes drafting, revising, and maintaining SOPs, as well as managing SOP Tracking and Training.
- Facilitate the market distribution of product batches.
- Address and resolve batch deviations, Out-of-Specification (OOS) reports, and proposed Corrective and Preventative Actions (CAPAs) from manufacturers for Dietary Supplements and Medical Foods.
- Manage product quality complaints effectively.
- Assist with FDA audits and inspections of the company or its manufacturing partners as required.
- 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 necessary.
Essential Qualifications, Education, and Experience:
- Bachelor's degree required (preferably in a technical or scientific field such as biology, chemistry, pharmacy, or a related science/technology discipline).
- 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 QA management capacity).
- Willingness to travel domestically to contract manufacturing sites, with potential for international travel for audits.
