QA Manager - Aseptic GMP Quality Systems Leader

Grand River Aseptic Manufacturing; Grand Rapids (MI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Benefits from day 1

401(k) immediate vesting

Paid volunteerism

PTO 13 days

Wellness time off

Paid holidays

Competitive pay

Job summary

Grand River Aseptic Manufacturing (GRAM) is seeking a leader to direct Quality Systems with oversight of Aseptic Manufacturing operations. The role requires a life sciences degree and 8+ years in GMP settings, including 4 years in management.

You will author and review cGMP documents, NCR investigations, and SOPs, while coordinating with regulators and clients. Strong communication and leadership are essential to drive timely, compliant outcomes.

Qualifications

• Bachelor's degree in Life Sciences or related field and 8+ years of experience in a GMP manufacturing setting.
• 4 years of prior management/leadership experience in GMP manufacturing.
• Knowledge of Quality principles and cGMP/FDA standards.

Responsibilities

• Lead and oversee GRAM Quality Systems and aseptic manufacturing operations.
• Author, review, and revise cGMP documents, NCR investigations, and SOPs.
• Communicate with management, regulators, and clients in written and verbal form.
• Allocate resources, manage priorities, and drive improvements in a fast-paced environment.

Skills

Technical writing

Regulatory communication

Leadership

Project management

Education

Bachelor's degree in Life Sciences or related

Job description

Grand River Aseptic Manufacturing (GRAM) is seeking a leader to direct Quality Systems with oversight of Aseptic Manufacturing operations. The role requires a life sciences degree and 8+ years in GMP settings, including 4 years in management.

You will author and review cGMP documents, NCR investigations, and SOPs, while coordinating with regulators and clients. Strong communication and leadership are essential to drive timely, compliant outcomes.