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.
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 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 work
- Health benefits and time-off programs
- Competitive compensation packages
- The anticipated annual salary for this role is $120,000 - 145,000
