Sr Manager, Quality Assurance

Breckenridge Pharmaceutical Inc

Job Description

About the Company

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.

About the Role

This position reports to the 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, Medical Foods or Foods for special dietary use.

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

Qualifications

Bachelor of Science 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)
Ability to travel domestically 3-4 times per year to perform audits on facilities, potential international travel

Required Skills

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Vacancy posted 29 days ago

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