Quality Auditor Principal-31465
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research, collaboration with the global patient community, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzyme's portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world's largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com
The Quality Auditor Principal provides oversight and compliance support for Corporate Quality Operations Quality Assurance (CQO-QA). This position is the process owner for the following quality processes and programs: Management of Suppliers and Subcontractors, Internal Audit and Walk-Through Inspection, and the External GxP Inspection. Directly responsible for ongoing management, maintenance and continuous improvement of these quality programs. Continually monitors quality indicators for trends, tracks, and report metrics. Routinely participates in continuous improvement initiatives; Observation Assessment Teams, Global Response Teams development, tracking and closure of CAPAs resulting from regulatory, GQA, Internal Audits and critical deviations. Maintains CQO's Site Inspection Readiness Tool (SIRT). Develops and provide training, as required for revised or new processes for CQO-QA including Inspection Readiness.
Maintain compliance requirements for established quality systems programs.
Complete analysis, identify issues and provide recommendations for compliance improvements.
Lead or support internal and external audits.
Perform review of results to audit process or equipment compliance to FDA and GMP requirements.
Provide guidance to less experienced staff.
Participate in determining objectives of significant projects or assignments.
Help remediate processes and systems in accordance with company standards and regulatory requirements.
Interact with project teams and applicable research groups as they impact the quality operation.
Associate Degree and 12 years of experience in Quality Assurance in a GMP environment
Bachelor's Degree and 9 years of experience in Quality Assurance in a GMP environment
American Society for Quality (ASQ) Certified Auditor
Experience participating in internal/vendor audits
Advanced knowledge in external agency regulations
Experience with Trackwise or equivalent system
Experience determining compliance trends
Experience with project management
Experience leading internal/supplier audits
Experience training employees to conduct audits
Experience working independently
Experience participating in external agency inspections (ie: FDA, EMA)
Knowledge of regulatory enforcement trends
Job : Quality
Primary Location : United States-Massachusetts-Framingham
Job Posting : Nov 5, 2012
Shift : Day Job
Job Type : Regular
Employee Status : Regular