Quality Systems & CI Lead — ISO/cGMP Expert

RR Donnelley & Sons

Pittsburgh (Allegheny County)

On-site

USD 74,000 - 116,000

Full time

9 days ago
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Benefits offered by this job

Medical benefits
Dental benefits
Vision benefits
401(k) with match
Paid time off
Parental leave
Tuition assistance

Job summary

RR Donnelley & Sons is seeking a site Quality Management professional to lead the implementation, maintenance, and continual improvement of the site QMS. You will drive high-impact projects to optimize cost, quality, and performance, serving as the primary site lead for continuous improvement and mentoring staff.

You will influence leadership, embed sustainable best practices, and act as a key driver of operational excellence across the site.

Qualifications

  • Bachelor's degree in a discipline related to the role.
  • Minimum 5 years' experience with ISO and cGMP oversight.
  • Strong problem solving, communication and leadership abilities.

Responsibilities

  • Lead the site QMS implementation, maintenance and improvement.
  • Provide root cause analysis and CAPA support to leadership.
  • Review CAPAs and corrective actions to minimize recurrence.
  • Oversee internal audits and QMS performance metrics.
  • Develop advanced process improvement to cut costs and boost quality.
  • Drive EHS programs and sustainability within projects.
  • Monitor training and maintain quality resources.
  • Ensure documentation and record retention conformity.
  • Identify and implement proactive injury-reduction programs.
  • Provide expertise in EHS initiatives and change management.

Skills

Leadership
Communication
Problem solving
Change management
Process improvement
Auditing
Documentation control
Mentoring
IT proficiency
Cross-functional collaboration

Education

Bachelor's degree in related field
Internal Auditor qualification
ISO/cGMP knowledge

Tools

Windows
macOS

Job description

RR Donnelley & Sons is seeking a site Quality Management professional to lead the implementation, maintenance, and continual improvement of the site QMS. You will drive high-impact projects to optimize cost, quality, and performance, serving as the primary site lead for continuous improvement and mentoring staff.

You will influence leadership, embed sustainable best practices, and act as a key driver of operational excellence across the site.

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