iSixSigma

Director of Healthcare Quality

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Berry Global, Inc
Published
March 8, 2021
Location
Indianapolis, IN
Job Type

Description

Location: Preferred locations: Indianapolis, IN or Greenville, SC. Would give consideration to other Eastern US locations

Responsibilities:

Responsibilities:
  • Develop and implement standardized quality systems across all CPI-NA healthcare sites
  • Ensure robust prevention, detection and containment systems are in place and sustained
  • Be the customer face of CPI-NA Healthcare Quality
  • Actively lead all significant quality incidents for the division
  • Work with the Global Healthcare team to translate learnings from quality incidents
  • Understand changing regulatory and customer requirements and implement systems and processes to stay current
  • Prepare monthly quality reviews to be presented to the divisional leadership team
  • Establish and drive accountability for quality KOMs
  • Drive a culture of continuous improvement
  • Provide support, coaching and direction to Manufacturing Quality Managers to achieve divisional Quality goals
  • Review major customer complaints and claims to identify opportunities for improvement
  • Assist Manufacturing to organize 3rd party audits of plants to ensure required compliance to ISO standards
  • Drive the management of Change Control Process for the division to ensure timely customer notification of changes
  • Review, negotiate and approve Customer Quality Agreements that are beneficial for both parties

Qualifications:

Required Qualifications:
  • 7+ years of Healthcare Quality leadership experience required
  • Bachelor’s Degree in a technical field or related combination of education & experience
  • Multi-site quality leadership experience a plus
  • Proficient understanding of cGMP, Quality Systems and Regulatory requirements for Healthcare packaging
  • Ability to fully Implement quality systems and standards
  • Up to 50% Travel required
  • Six Sigma Black Belt certification a plus
  • Strong organizational and leadership skills combined with superior communication skills
  • Demonstrated ability to provide guidance and leadership to others
  • Demonstrated ability to develop & lead a high-performing team environment
  • Working knowledge of ISO standards, SPC and Six Sigma
  • Experience with various 3rd party audits

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