- Entry level
- No Education
- Salary to negotiate
Quality Director - 00001QUK
Are you looking to make a difference in a patient’s life? At AmerisourceBergen, you will find an innovative culture that is patient focused and dedicated to making a difference. As an organization, we are united in our responsibility to create healthier futures.
What you will be doing
PharMEDium, an AmerisourceBergen Company is the leading provider of pharmacy-outsourced, ready-to-use compounded sterile preparations (CSPs). The Director of Quality serves as a single point of quality at a facility. This position reports to the Vice President of Quality and R&D. The Director must be familiar with and knowledgeable of cGMP/GLP and 21 CFR Part 11 procedures. All applicants for this position must embody and demonstrate the PharMEDium Core Values: Patient Safety, Flawless Quality, Operational Excellence, Employee Well Being, Service Excellence, and Respectful and Collaborative Environment.
Develop, implement, maintain and continually assess quality management system for applicable regulated activities to meet internal company standards and external regulatory and customer requirements, including but not limited to the following tasks:
• Management of all QC laboratory testing (Chemistry, Microbiology, Environmental and Personnel Monitoring samples).
• Management of method and product transfers across multiple centers (and contract testing laboratories).
• Oversight of robust aseptic processing behaviors by implementing stringent requirements and implementation of Quality presence on the floor to proactively identify opportunities for improvement.
• Management of an effective and efficient Batch Release process.
• Management of an effective EM/PM program for the center.
• Management of effective training program.
• Management of an effective customer complaint management program.
• Administering policies and standard operating procedures (SOPs) relating to QA, QC, and the quality management system
• Using incident (Investigations) and Corrective and Preventive Action (“CAPA”) activities and processes to drive quality improvements and respond to process and service issues
• Ensuring the center is “inspection ready”. Responsible for representing and leading the company during audits, visits, and technical calls.
• Implementation of a robust DEA program for the center (as applicable)
• Define, develop and implement short-term and long-term strategies, goals, objectives and tactics relating to the quality assurance function and the quality management system
• Keep senior management appraised of quality issues as needed
• Develop departmental key performance indicators (KPI) and analyze for opportunities to optimize department performance.
• Builds effective partnerships with department heads to help drive the business toward achieving company objectives.
• Embody PharMEDium’s cultural values and aligns daily actions with department goals and company culture.
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
What your background should look like (minimum qualifications)
1. Bachelor’s degree in a life science. Advanced degree preferred.
2. 12+ years of pharmaceutical analytical laboratory experience and significant years of leadership of multiple staff members and team.
3. Experience in a FDA regulated industry. Aseptic manufacturing experience is preferred.
4. Previous work experience in a Quality leadership role, including all aspects of quality processes, development and execution.
1. Actively participated in audits (internal and regulatory) with independent close out of observations
2. Effective organization and planning skills
3. Excellent technical and verbal skills
4. Must have the ability to multi-task
5. Have problem solving skill set
6. Computer knowledge of data collection systems Empower and Win60, spreadsheet software, Microsoft Word, Excel, and PowerPoint
7. Understanding and Experience utilizing the USP Compendia methods
8. Ability to travel up to 10%
What AmerisourceBergen offers
We offer competitive total rewards compensation. Our commitment to our associates includes benefit programs that are comprehensive, diverse and designed to meet the various needs across our associate population.
• Healthcare for associates and eligible dependents,
About the company
AmerisourceBergen (NYSE: ABC) is one of the world’s largest pharmaceutical sourcing and distribution services companies, working alongside healthcare providers and pharmaceutical manufacturers to improve access to products and enhance patient care.
With services ranging from drug distribution and supply chain management to patient support solutions and pharmaceutical commercialization, AmerisourceBergen enables quality care and innovation in human and animal health. Tens of thousands of pharmacies, physician practices, health systems, veterinary practices, livestock producers and pharmaceutical manufacturers turn to AmerisourceBergen for the expertise they need to drive business performance.