Aseptic QA Program Lead – GMP & Impact

Grand River Aseptic Manufacturing Inc.; Grand Rapids, Northern (MI, KY); Hybrid; USD 110,000 - 140,000; Full time

Benefits offered by this job

Medical insurance

Prescription coverage

Dental insurance

Vision insurance

Life insurance

Disability benefits

401(k) vesting on day one

Paid volunteer time

Job summary

Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, MI seeks a leader to direct the Quality Systems with oversight of aseptic manufacturing operations. The role emphasizes strong technical writing, regulatory alignment, and the ability to drive compliant improvements across the site.

The ideal candidate holds a Life Sciences degree with 8+ years in GMP environments, plus 4 years in a management role, and a solid track record in cGMP, FDA guidelines, and cross-functional collaboration with

Qualifications

• Bachelor’s degree in Life Sciences or related field and/or 8+ years related work experience.
• 4 years of leadership/management experience in a GMP manufacturing environment.
• Knowledge of Quality principles and procedures in pharma/biopharma/biotech manufacturing.
• Thorough understanding of cGMP, FDA guidelines and multinational regulatory standards.

Responsibilities

• Strong technical writing and documentation skills, including cGMP docs, NCR investigations, SOPs in a regulated aseptic environment.
• Interpreting and applying Quality standards for implementation and review.
• Maintain integrity and professionalism at all times.
• Communicate effectively with management, staff, regulators and client representatives in writing and verbally.
• Complete tasks accurately and on established timelines.
• Demonstrated management ability to lead teams to meet objectives.
• Make sound decisions on scheduling, resource allocation, and priorities.
• Identify areas of improvement and proactively drive solutions in a fast-paced aseptic setting.

Skills

Quality Systems

cGMP Knowledge

Regulatory Knowledge

Documentation Writing

Leadership

Interpersonal Communication

Education

Bachelor's degree in Life Sciences

Job description

Grand River Aseptic Manufacturing (GRAM) in Grand Rapids, MI seeks a leader to direct the Quality Systems with oversight of aseptic manufacturing operations. The role emphasizes strong technical writing, regulatory alignment, and the ability to drive compliant improvements across the site.

The ideal candidate holds a Life Sciences degree with 8+ years in GMP environments, plus 4 years in a management role, and a solid track record in cGMP, FDA guidelines, and cross-functional collaboration with