For The Candidates

Qa Dr Capa Quality Assurance- Device
IL
Type: Full-Time
Category: Quality Assurance
Job ID: 817
Opportunity Description:
(847)  Area Code   Chicago Area   
 

Business Title   Director, Medication Delivery CAPA

 

Job Description

  1. Provide divisional leadership and oversight in ensuring compliant and effective CAPA execution in Medication Delivery (MD).
  2. Assess and improve the consistency, quality, and timeliness of MD divisional CAPA execution through implementing and maintaining effective CAPA monitoring systems and review mechanisms.
  3. Interface with senior management, peers, and subordinates to identify required CAPA system and process improvement initiatives across the division. This includes but is not limited to the remediation of CAPA system and process deficiencies noted in audits and/or inspections.
  4. Remain conversant with the appropriate regulations, laws and standards to maintain MD CAPA process compliance, and to provide up to date guidance and training.
  5. Interface with auditors/inspectors relating to the MD CAPA system and process.
  6. Grow and maintain team of CAPA experts/mentors to provide divisional guidance on expected CAPA execution.
  7. Develop and deliver CAPA training to ensure MD divisional knowledge of CAPA requirements, process and individual responsibilities is known and maintained.

 

Job Requirements

  1. Bachelors degree required, Masters degree strongly preferred.
  2. 10 years minimum of experience in Quality function in a regulated medical industry.
  3. 5 years minimum of CAPA managerial experience in a regulated medical industry.
  4. Proven ability to drive change across organization utilizing strong relationship management skills and ability to influence in a matrix environment at multiple levels.
  5. Experience interacting with FDA & ISO regulatory auditors/inspectors as pertaining to CAPA
  6. Strong organizational and communication skills, with a demonstrated ability to recruit, motivate, and guide teams of professionals.
  7. Strong knowledge and understanding of applicable CAPA system regulations and standards (e.g. 21CFR 820.100, ISO9001, ISO13485).
 
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