QA Leader, Aseptic Manufacturing Quality Systems

Grand River Aseptic Manufacturing, Inc.; Grand Rapids (MI); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

Medical, prescription, dental, vision,

Life insurance

Disability benefits

401(k) vesting

Volunteer time

PTO 13 days

Wellness time off

Paid holidays

Job summary

Grand River Aseptic Manufacturing, Inc. is seeking a senior leader to provide direction and oversight of Quality Systems for Aseptic Manufacturing operations, ensuring compliance with cGMP, FDA guidelines and global standards.

The role requires a life sciences degree or equivalent with 8+ years in GMP, plus 4+ years of management experience; strong technical writing, regulatory interaction, and the ability to lead teams in a fast-paced manufacturing environment.

Qualifications

• Bachelor’s degree in Life Sciences or related field (or equivalent experience).
• 4 years of management/leadership experience in GMP manufacturing.
• Knowledge of Quality principles and procedures in pharma/biotech environments.
• Understanding of cGMP, FDA guidelines and multinational standards.
• Experience interacting with regulatory authorities is a plus.
• Experience in aseptic manufacturing of regulated products.

Responsibilities

• Author, review and revise cGMP documentation, NCR investigations and SOPs with high accuracy in a regulated aseptic setting.
• Interpret and apply Quality standards for implementation and review.
• Communicate effectively with management, regulators and client representatives.
• Lead teams to meet objectives and manage scheduling and priorities.
• Proactively identify improvements and drive solutions in a fast-paced aseptic environment.

Skills

Quality principles

cGMP & FDA guidelines

Regulatory interactions

Management / leadership

Aseptic manufacturing

Education

Bachelor’s degree in Life Sciences or related field

Job description

Grand River Aseptic Manufacturing, Inc. is seeking a senior leader to provide direction and oversight of Quality Systems for Aseptic Manufacturing operations, ensuring compliance with cGMP, FDA guidelines and global standards.

The role requires a life sciences degree or equivalent with 8+ years in GMP, plus 4+ years of management experience; strong technical writing, regulatory interaction, and the ability to lead teams in a fast-paced manufacturing environment.