Senior Quality Assurance Manager
: Job Details :

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.

The Senior Quality Assurance Manager reports to the Associate Vice President, Quality Assurance and will manage 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, Medical Foods or Foods for special dietary use.

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
• Manage 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
• Manage investigation and follow-up on product quality complaints
• Manage the QA review and internal market distribution procedure for ANDA drug product, OTC, Dietary Supplement and Medical Food products
• 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
• Batch record reviews, as required

ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE

· BS required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)

· Minimum 10 years' experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems (preferably at least 5 years in a QA-management role)