Senior QA Systems & Document Control Leader

Grand River Aseptic Manufacturing Inc.; Grand Rapids (MI); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health benefits

401(k) vesting

Volunteer time

PTO

Wellness time

Paid holidays

Competitive pay

Job summary

Grand River Aseptic Manufacturing (GRAM) is seeking a QA Systems and Document Control Manager to lead document control and quality systems ensuring cGMP compliance. You will manage creation, revision, approval, and maintenance of controlled documents, and oversee NCRs, CAPAs, and Change Management.

You will partner across manufacturing and quality teams, drive continuous improvement, and serve as SME for process effectiveness, with a disciplined, science-based approach and strong communication

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 5–10+ years in Quality/Technical Operations in pharma/manufacturing.
• Strong knowledge of cGMP and FDA requirements.
• Experience with Lean Six Sigma and RCA tools.
• Experience with eQMS such as MasterControl.

Responsibilities

• Lead document control and quality systems to ensure cGMP compliance.
• Manage lifecycle of controlled documentation (creation, revision, approval, maintenance).
• Oversee NCRs, CAPAs, and Change Management.
• Serve as SME to drive process improvements and compliance.
• Collaborate cross-functionally with all departments to support manufacturing and quality objectives.

Skills

cGMP knowledge

FDA requirements

Lean Six Sigma

Root Cause Analysis

Cross-functional leadership

eQMS MasterControl

Education

Bachelor's degree in Life Sciences

Tools

MasterControl

Job description

Grand River Aseptic Manufacturing (GRAM) is seeking a QA Systems and Document Control Manager to lead document control and quality systems ensuring cGMP compliance. You will manage creation, revision, approval, and maintenance of controlled documents, and oversee NCRs, CAPAs, and Change Management.

You will partner across manufacturing and quality teams, drive continuous improvement, and serve as SME for process effectiveness, with a disciplined, science-based approach and strong communication