About this opportunity
Breckenridge Pharmaceutical lists this Senior Quality Assurance Manager (Berkeley Heights) opportunity in berkeley heights, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
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.
Worksite address
berkeley heights, NJ, 07922, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.