Quality Operations Leader — GMP & Compliance

Aquestive Therapeutics, Inc.; Portage (IN); On-site; USD 110,000 - 150,000; Full time

Job summary

Aquestive Therapeutics, Inc. in Portage, IN is seeking a senior QA/QC professional to lead day-to-day quality oversight of manufacturing and operations, ensuring cGMP compliance and robust risk management across a multi-site operation.

The role emphasizes leading deviations/investigations, batch release, and collaboration with Manufacturing, QC, and Supply Chain to sustain a state of audit readiness and continuous improvement.

Qualifications

• Bachelor’s degree in Science, Engineering, or related field.
• 7–10 years of GMP pharmaceutical manufacturing QA/QC experience.
• Previous people management or strong informal leadership experience.
• Expertise in cGMP regulations (FDA/EU).
• Experience with quality systems (CAPA, deviations, change control).
• Experience in Manufacturing and/or QC operations.
• Strong PM skills and organizational ability with budget awareness.

Responsibilities

• Provide daily QA oversight of manufacturing and packaging operations across multi-site/multi-shift.
• Manage product quality release program ensuring on-time results and adherence to procedures.
• Provide real-time risk assessment and containment actions.
• Review and release batch records.
• Author/review/approve quality documentation for manufacturing.
• Ensure SOPs, batch records, and GMP compliance.
• Lead deviations, OOS, complaints, and investigations with robust root cause analysis and CAPAs.
• Manage QA personnel, priorities, staffing, and shift coverage.
• Oversee incoming materials QA/QC review and release to procedures.
• Coach on GMP decision-making and risk-based quality judgment.
• Monitor quality metrics and drive continuous improvement.

Skills

GMP QA

Project management

Leadership

cGMP regulations

Education

Bachelor's degree (Science/Engineering)

Tools

CAPA system

Change control

Deviations management

Job description

Aquestive Therapeutics, Inc. in Portage, IN is seeking a senior QA/QC professional to lead day-to-day quality oversight of manufacturing and operations, ensuring cGMP compliance and robust risk management across a multi-site operation.

The role emphasizes leading deviations/investigations, batch release, and collaboration with Manufacturing, QC, and Supply Chain to sustain a state of audit readiness and continuous improvement.