Manager Quality Assurance

Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.

This position reports to the Associate Vice President, Quality Assurance and will manage or support: cGMP compliance assessment of contract manufacturers, the company SOP and Training systems, QA/QC Testing /Audit program, and Quality/Compliance decisions related to the Company’s ANDA products, as well as its products subject to OTC Monographs and FDA or other industry-accepted standards for Dietary Supplements and Medical Foods.

DUTIES AND RESPONSIBILITIES:

• Perform, support and evaluate third party audits of current and proposed vendors for cGMP compliance
• Manage the SOP system, including writing/ revising and maintaining SOPs, SOP Tracking and SOP Training
• Support market distribution of batches
• Manage the review 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
• Support FDA audits/inspections of the company or its manufacturing partners, as needed
• Product Quality Reviews, including review of manufacturers' reports of annual product reviews
• Manage change control review of Dietary Supplements and Medical Foods products
• Batch record reviews, as required

ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE

• BS required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)
• Minimum 7 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems (preferably at least 2 years in a QA-management role)
• Ability to travel domestically to contract manufacturing sites, chance of international travel for audits