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Quality Director

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: o Management of all QC laboratory testing (Chemistry, Microbiology, Environmental and Personnel Monitoring samples). o Management of method and product transfers across multiple centers (and contract testing laboratories). o Oversight of robust aseptic processing behaviors by implementing stringent requirements and implementation of Quality presence on the floor to proactively identify opportunities for improvement.  o Management of an effective and efficient Batch Release process. o Management of an effective EM/PM program for the center. o Management of effective training program.   o Management of an effective customer complaint management program. o Administering policies and standard operating procedures (SOPs) relating to QA, QC, and the quality management system o Using incident (Investigations) and Corrective and Preventive Action ("CAPA") activities and processes to drive quality improvements and respond to process and service issues o Ensuring the center is "inspection ready". Responsible for representing and leading the company during audits, visits, and technical calls. o Implementation of a robust DEA program for the center (as applicable) o 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 o Keep senior management appraised of quality issues as needed o Develop departmental key performance indicators (KPI) and analyze for opportunities to optimize department performance. o Builds effective partnerships with department heads to help drive the business toward achieving company objectives. o Embody PharMEDium's cultural values and aligns daily actions with department goals and company culture. o 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. o Healthcare for associates and eligible dependents, same-sex and domestic partners o Paid time off, including vacations and holidays o Paid volunteer time off o Life insurance and disability protection o Pet insurance o Employee Stock Purchase Program o Retirement benefits and more... Throughout our global footprint and various business units, we take a balanced approach to the benefits we offer. Many benefits are company-paid, while others are available through associate contributions. Specific benefit offerings may vary by location, position and/or business unit.  00001QUK
Salary Range: NA
Minimum Qualification
11 - 15 years

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