QA Manager – Aseptic GMP, Regulatory Excellence

Socket.dev; Grand Rapids (MI); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid volunteer time

PTO

Wellness time off

Paid holidays

Job summary

Grand River Aseptic Manufacturing (GRAM) seeks a senior leader to direct the Quality Systems with oversight of aseptic manufacturing operations in Grand Rapids, Michigan. You will shape quality strategy, ensure compliance with cGMP, and partner with regulatory authorities as needed.

The role requires strong technical writing, exceptional leadership, and a proactive approach to risk management, investigations, and continuous improvement in a fast-paced environment.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 8+ years GMP leadership experience.
• GMP manufacturing knowledge.
• Understanding of cGMP and FDA guidelines.

Responsibilities

• Lead GRAM Quality Systems with oversight of aseptic manufacturing operations.
• Author and review cGMP documents, NCR investigations, and SOPs.
• Interface with regulators and client representatives.
• Manage scheduling, resources, and priorities.
• Drive continuous improvement in a fast-paced aseptic environment.

Skills

Quality systems

Document control

Leadership

Regulatory knowledge

cGMP

Education

Bachelor’s degree in Life Sciences

8+ years GMP experience

Job description

Grand River Aseptic Manufacturing (GRAM) seeks a senior leader to direct the Quality Systems with oversight of aseptic manufacturing operations in Grand Rapids, Michigan. You will shape quality strategy, ensure compliance with cGMP, and partner with regulatory authorities as needed.

The role requires strong technical writing, exceptional leadership, and a proactive approach to risk management, investigations, and continuous improvement in a fast-paced environment.