Senior Quality Assurance Manager
About the CompanyBreckenridge 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 RoleThis 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.ResponsibilitiesPerform, support and evaluate third party audits of current and proposed vendors for cGMP complianceManage the SOP system, including writing/ revising and maintaining SOPs, SOP Tracking and SOP TrainingSupport market distribution of batchesManage 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 FoodsManage product quality complaintsSupport FDA audits/inspections of the company or its manufacturing partners, as neededProduct Quality Reviews, including review of manufacturers' reports of annual product reviewsManage change control review of Dietary Supplements and Medical Foods productsBatch record reviews, as requiredQualificationsBachelor 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 travelRequired SkillsStrong knowledge of quality and compliance for drug productionStrong knowledge of cGMP regulations (21 CFR 210 and 211 and 21 CFR 110 and 111)Strong leadership skillsExcellent attention to detail and organizational skillsEffective communication and interpersonal skillsPay range and compensation packageAt 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 workHealth benefits and time-off programsCompetitive compensation packagesThe anticipated annual salary for this role is $120,000 – 145,000Equal Opportunity StatementBreckenridge 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.