Senior QMS & Continuous Improvement Lead (ISO/cGMP)

RRD Company; Pittsburgh, Northern (Allegheny County, KY); Hybrid; USD 74,000 - 116,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Parental leave

Job summary

RRD is seeking a qualified quality leader to manage and improve the site Quality Management System (QMS) and its performance from administration and customer service. You will lead high-impact projects to optimize cost, quality, and operational performance, acting as the primary site lead for continuous improvement and guiding others in advanced methodologies and change management.

Responsibilities include ensuring ISO/cGMP compliance, driving CAPA activities, auditing, and mentoring staff to

Qualifications

• Bachelor degree in discipline related to functional work is required.
• 5+ years of relevant experience including ISO and cGMP oversight.
• Strong analytical, prioritization and problem-solving skills.

Responsibilities

• Provides leadership for QMS, ensuring compliance with ISO, cGMP and corporate quality standards.
• Provides root cause analysis and corrective/preventive action plan support to site leadership.
• Reviews, CAPAs, spoilage incidents, and other errors for designated high risk accounts, and reviews and approves root cause analysis efforts by site leadership, and corrective/preventive actions to ensure the risk of repeat occurrence is reduced or eliminated.
• Oversees internal audits and QMS performance metrics, presenting findings to site leadership through regular Management Reviews.
• Develops and deploys advanced process improvement methodologies to optimize cost, quality, and efficiency.
• Leads improvement projects, including EHS program development and sustainability for assigned programs.

Skills

Leadership

Communication

Problem solving

Auditing

Quality management

Education

Bachelor degree in discipline related to functional work

Tools

Document control systems

Microsoft Windows / Mac

Job description

RRD is seeking a qualified quality leader to manage and improve the site Quality Management System (QMS) and its performance from administration and customer service. You will lead high-impact projects to optimize cost, quality, and operational performance, acting as the primary site lead for continuous improvement and guiding others in advanced methodologies and change management.

Responsibilities include ensuring ISO/cGMP compliance, driving CAPA activities, auditing, and mentoring staff to