Sr Manager, Quality Assurance

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

• Strong knowledge of quality and compliance for drug production
• Strong knowledge of cGMP regulations (21 CFR 210 and 211 and 21 CFR 110 and 111)
• Strong leadership skills
• Excellent attention to detail and organizational skills
• Effective communication and interpersonal skills

Pay range and compensation package

At Breckenridge Pharmaceutical Inc, we’re committed to investing in every team member’s total well-being, now and in the future. Our benefits programs vary but we offer the following to all BPI team members, regardless of geographic location:

• Flexible approach to how we work
• Health benefits and time-off programs
• Competitive compensation packages