Quality Assurance Manager at Pharmaceutical Company in Tempe, Arizona, United States —
- Pharmaceutical Company
- Tempe, Arizona, United States USA
- 5/23/19 2019-05-23
Job ID: 37072
Enhance, maintain, and continuously improve SDC’s QMS.
• Conduct internal audits for proper adherence to established procedures.
• Serve as QMS subject matter expert (SME) in meetings, as required.
• Develop quality goals and objectives and communicate same to the management team.
• Develop study level quality plan template
• Lead development of partner quality agreements
• Support business development and strategic planning activities, as required.
• Act as a quality assurance liaison with internal and external cross-functional teams, clients, and suppliers, as well as project team meetings, as required.
• Develop and maintain quality assurance related metrics to help the company understand how it is performing with respect to quality.
• Analyze quality metrics on a regular basis for performance trends requiring management attention.
• Help prepare, revise and control the company’s SOP’s.
• Investigate and report on quality assurance related issues to include root cause and corrective action identification and implementation monitoring.
• Host government regulatory, sponsor, and third party audits of the company’s QMS.
• Ensure the quality department demonstrates complete adherence to the company’s QMS.
• Prepare and deliver effective training courseware to company personnel.
• Prepare department budgets, track budget status regularly and make course corrections as necessary.
• Spearhead initiatives to improve company operations while ensuring high quality outputs.
• Comply with SDC’s integrity & business ethics requirements.
• Perform other duties as assigned.
• Demonstrated management/supervisor related experience.
• Excellent leadership and management abilities.
• Strong ability to motivate company personnel to adhere to quality policies and procedures.
• Strong aptitude in the art and science of quality, CMC, and preclinical procedures and methods.
• Solid independent thinking ability and demonstrated ability to discern multiple viewpoints.
• Good working knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations.
• Strong understanding of international regulations regarding clinical research (EMEA, PMDA, Health Canada, etc.)
• Good analytical skills with the ability to evaluate data trends for lessons learned required action, etc.
• Demonstrated ability to conduct root cause analysis and to prepare written remediation plans.
• Keen ability to accurately discern priorities in a resource constrained work environment.
• Demonstrated process auditing and improvement skills and aptitude.
• Ability to effectively train and educate internal staff on procedures and regulatory issues.
• Demonstrated ability to develop effective procedures and to write clear, consistent, thorough SOP’s.
• Experience working closely with FDA in either audit scenarios or through prior employment.
• Excellent verbal and written communication skills.
Bachelor’s degree in applied life science or business with at least eight (8) years of increasing experience in a related quality assurance position, at least 5 of those years in supporting clinical trial operations. An MBA or other related advanced degree is preferred.