Description

This position is accountable for assessing and reporting company compliance with international  &/or  FDA  regulatory requirements through managing and developing all aspects of the BD internal and external audit program, and driving the timely completion of effective preventive and corrective actions associated with audit nonconformities.  This position will be primarily focused on Good Clinical Practices (GCP)
 
This individual will have the following responsibility to:
  • Manage and assure compliance of the BD audit program with all regulatory requirements and company policies
  •  Makes recommendations to management for risk-based decisions based on data, knowledge, compliance and business impact
  • Assists in the management of systems across the business to assure compliance to audit observations, non-conformities, internal and external (supplier) preventive and corrective action plans, and assists in the verification of corrective action implementation and effectiveness
  • Engages the Supplier Management Action and /or Strategy leadership Team as required, ensuring the development and execution of BD’s external (supplier) audit program.
  • Manages best practices across the assigned area of accountability and promotes the inclusion of best practices where opportunities or deficiencies are identified
  • Serves as a knowledge resource to assist in providing regulatory compliance and  audit training
  • Partners with other quality professionals to address recurring issues identified throughout the organization
  • Manage organizational quality metrics as required to generate quality system improvements
  • Partners with leadership team to review areas of nonconformance and review corrective and preventive action plans
  • Manage the staff of the Auditing department

Qualifications
  •  Firm knowledge of applicable regulatory requirements such as: Quality Systems Regulations (QSR), ISO, FDA, ICH, GCP/GLP , country-specific regulations, and all applicable International standards
  • Working knowledge of major processes as related to the medical device industry
  • Effective written and verbal communication skills at all levels of management
  • Ability to perform multiple tasks and effectively manage conflict
  • Ability to lead and manage teams to obtain results
  • Self motivated/directed
  • Ability to organize and supervise people and activities, and resource management
  • Managing through influence
  • Training and Presentation skills
Apply