QA Systems & Document Control Leader — cGMP & Compliance

Grand River Aseptic Manufacturing; Grand Rapids (MI); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Medical benefits day 1

Volunteer time off

Paid time off

Wellness time off

Paid holidays

Competitive pay

Job summary

Grand River Aseptic Manufacturing (GRAM) seeks a QA Systems and Document Control Manager to lead Document Control and Quality Systems, ensuring compliance with cGMP and regulatory expectations. You will oversee the lifecycle of controlled documents and related quality processes.

The ideal candidates have 5–10+ years in Quality/Technical Operations within pharma or manufacturing, strong knowledge of cGMP and FDA requirements, and experience with eQMS tools such as MasterControl; a proven

Qualifications

• Bachelor's degree in Life Sciences or 5–10+ years in QA/Tech Ops in pharma/manufacturing.
• Strong knowledge of cGMP and FDA requirements.
• Experience with Lean Six Sigma and RCA tools.
• Experience leading cross-functional teams and eQMS systems.

Responsibilities

• Interpret and apply quality standards across the organization.
• Lead cross-functional teams and drive accountability.
• Communicate and influence stakeholders at all levels.
• Manage multiple priorities in a fast-paced environment.
• Lead initiatives to improve compliance and efficiency.
• Uphold integrity and customer focus.

Skills

cGMP knowledge

FDA requirements

Lean Six Sigma

RCA techniques

Cross-functional leadership

eQMS experience

Education

Bachelor's degree in Life Sciences or related field

Tools

MasterControl

Job description

Grand River Aseptic Manufacturing (GRAM) seeks a QA Systems and Document Control Manager to lead Document Control and Quality Systems, ensuring compliance with cGMP and regulatory expectations. You will oversee the lifecycle of controlled documents and related quality processes.

The ideal candidates have 5–10+ years in Quality/Technical Operations within pharma or manufacturing, strong knowledge of cGMP and FDA requirements, and experience with eQMS tools such as MasterControl; a proven