Available Positions

Quality Assurance Manager at Pharmaceutical Company in Tempe, Arizona, United States —

  • Pharmaceutical
  • Pharmaceutical Company
  • Tempe, Arizona, United States
  • 5/23/19

Job ID: 37072

Job Description

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.
REQUIREMENTS
•    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.
 

Qualifications

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.
 

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