Senior QMS & Continuous Improvement Lead

RR Donnelley; Pittsburgh (Allegheny County); On-site; USD 74,000 - 116,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

401(k) with company match

Life insurance

Paid time off

Job summary

RR Donnelley seeks a proactive Quality Management System (QMS) leader to drive ISO and cGMP compliance and lead site improvement initiatives in the Administration & Customer Service department. You will mentor staff, guide change management, and coordinate audits to elevate quality and efficiency across the site.

The role requires 5+ years of experience, a related Bachelor's degree, and strong communication, problem-solving, and leadership skills.

Qualifications

• Bachelor's degree in discipline related to functional work is required.
• At least 5 years of relevant experience including overseeing ISO and cGMP.
• Ability to analyze complex problems and identify critical elements and solutions.
• Strong business acumen and collaborative skills for problem resolution.
• Excellent communication skills and ability to convey messages clearly.
• Understanding of computer systems (Windows/MAC) and ability to mentor others in their use.
• Knowledge of document control standards and organizational integrity.
• Demonstrated leadership, facilitation, coaching and organization skills.
• Internal Auditor or Lead Auditor qualification or experience required.
• Knowledge of ISO quality management systems and cGMP/SOC2+ preferred.

Responsibilities

• Provides leadership for QMS and ensures compliance with ISO, cGMP and corporate standards.
• Performs root cause analysis and CAPA support for site leadership.
• Reviews CAPAs, spoilage incidents, and other errors for high risk accounts and approves corrective actions.
• Oversees internal audits and QMS performance metrics and presents findings in Management Reviews.
• Develops and deploys advanced process improvement methodologies to optimize cost, quality, and efficiency.
• Leads improvement projects including EHS program development and sustainability.
• Monitors quality training requirements and ensures adequate trained resources.
• Maintains documentation and record retention standards and supports proactive safety programs.

Skills

Leadership

Communication

Auditing

ISO knowledge

cGMP knowledge

Change management

Education

Bachelor's degree in related discipline

Tools

Windows

macOS

QMS software

Job description

RR Donnelley seeks a proactive Quality Management System (QMS) leader to drive ISO and cGMP compliance and lead site improvement initiatives in the Administration & Customer Service department. You will mentor staff, guide change management, and coordinate audits to elevate quality and efficiency across the site.

The role requires 5+ years of experience, a related Bachelor's degree, and strong communication, problem-solving, and leadership skills.