GMP Compliance Manager, Manufacturing Operations

Pharmgate Animal Health LLC; Omaha (NE); On-site; USD 90,000 - 120,000; Full time

Job summary

Pharmgate Animal Health LLC in Omaha, NE seeks a Manufacturing Compliance Manager to oversee quality and regulatory compliance for manufacturing operations. The role develops processes, procedures, and policies to meet standards and analyzes data to identify trends and drive improvements.

Reporting to the Director of Manufacturing, the MCM ensures compliance with FDA/cGMP, maintains SOPs, authors deviation and investigation reports, and supports CAPA, IQ/OQ, and change controls within a quality

Qualifications

• Bachelor of Science degree in Chemistry, Microbiology or Biology or related field.
• Minimum five (5) years’ experience in a cGMP manufacturing setting with an emphasis on quality focus experience; preferably in a pharmaceutical production facility.

Responsibilities

• Ensure manufacturing operates in accordance with FDA current Good Manufacturing Practice (GMP) requirements and guidelines.
• Maintain SOPs per company policy using industry procedures and techniques.
• Interpret analytical findings to assess compliance or non-compliance and escalate as needed.
• Complete company required forms for project assignments.
• Track non-compliance with detailed records for SOPs and training.
• Provide non-compliance reports to area leadership.
• Develop real-time batch record review systems with Manufacturing Quality for accurate edits.
• Ensure compliance with applicable laws, regulations, and guidelines.
• Provide safety compliance updates to Manufacturing Director.
• Participate in team meetings and support training and talent development.
• Investigate deviations, author CAPA, and report analytical testing results.
• Perform technical writing and other duties as assigned.

Skills

cGMP knowledge

Regulatory knowledge

Collaboration

Driver's license

Analytical skills

Communication

Time management

MS Office

Excel

Word processing

Education

B.S. in Chemistry / Microbiology / Biology

Tools

SAP Business One

Job description

Pharmgate Animal Health LLC in Omaha, NE seeks a Manufacturing Compliance Manager to oversee quality and regulatory compliance for manufacturing operations. The role develops processes, procedures, and policies to meet standards and analyzes data to identify trends and drive improvements.

Reporting to the Director of Manufacturing, the MCM ensures compliance with FDA/cGMP, maintains SOPs, authors deviation and investigation reports, and supports CAPA, IQ/OQ, and change controls within a quality