Sr Manager, Quality Assurance

Job Description

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

• 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
• The anticipated annual salary for this role is $120,000 – 145,000

Equal Opportunity Statement

Breckenridge Pharmaceutical, Inc is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.