The Associate Director, Quality Systems will ensure that required quality exists in all Quality System functions as prescribed by the ISO9001 and relevant GMPs. It will also organize and manage the divisions Quality Systems personnel and activities including Quality Assurance and Quality Control. Council the organization on quality best practices and enforce compliance to the SOP’s and applicable regulations. Plan and carry out activities to improve the quality system functions to ensure compliance and efficiency.
Provides leadership and guidance to the Quality Systems team to ensure the development and implementation of strategies regarding processes, procedures and quality standards are maintained in compliance with applicable regulations
Provides ongoing development of the Quality Systems team including staff selection, work assignments, goal completion, coaching, development plan review and performance management
Establishes strong partnerships/relationships with business stakeholders
Acts as a quality resource with expertise in quality regulations relating to GMP and ISO guidelines
Direct activities related to the preparation for and conduct of regulatory and Notified Body inspections and customer activities
Responsible for the performance of the Quality Management Systems of the organization
Trend and analyze Quality Indicators and Key Performance Indicators to drive continuous improvement within the department and organization. Provide input and direction for corrective and preventive actions and suggest plans for improvement based on KPI results.
B.S. or B.A.
5 + years of direct Quality Systems experience in the medical device and/or pharmaceutical industry
5+ years of management experience
Detailed knowledge of ISO9001 and general understanding of medical device or pharmaceutical GMPs
Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
To all agencies: Please, no phone calls or emails to any employee of Fujifilm about this requisition. All resumes submitted by search firms/employment agencies to any employee at Fujifilm via-email, the internet or in any form and/or method will be deemed the sole property of Fujifilm, unless such search firms/employment agencies were engaged by Fujifilm for this requisition and a valid agreement with Fujifilm is in place. In the event a candidate who was submitted outside of the Fujifilm agency engagement process is hired, no fee or payment of any kind will be paid.