Senior Quality Operations Lead (GMP)

Aquestive Therapeutics; Portage (IN); On-site; USD 85,000 - 115,000; Full time

Job summary

Aquestive Therapeutics is seeking a Quality Assurance Lead in Portage, Indiana. This role requires oversight of manufacturing quality, adherence to GMP regulations, and expert risk management.

You will lead a team ensuring compliance, managing quality operations, and working collaboratively with manufacturing and supply chain sectors. Applicants should have 7–10 years of relevant pharmaceutical manufacturing QA/QC experience, a Bachelor's degree in a related field, and strong project management capabilities.

Qualifications

• 7–10 years in GMP pharmaceutical manufacturing QA/QC experience.
• Prior people management or strong informal leadership experience.
• Some travel required.

Responsibilities

• Lead daily GMP oversight, providing real-time QA oversight.
• Manage product quality release program and ensure adherence.
• Review and release batch records and approve quality documentation.
• Monitor key quality metrics to identify trends.
• Act as a primary QA partner to Manufacturing and Quality Control.

Skills

cGMP regulations (FDA / EU)

Quality systems (CAPA, deviations, change control)

Strong project management skills

Excellent computer skills

Strong organizational skills

Strong business acumen

Education

Bachelor’s degree (Science, Engineering, or related)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Visio

Microsoft Access

Job description

Aquestive Therapeutics is seeking a Quality Assurance Lead in Portage, Indiana. This role requires oversight of manufacturing quality, adherence to GMP regulations, and expert risk management.

You will lead a team ensuring compliance, managing quality operations, and working collaboratively with manufacturing and supply chain sectors. Applicants should have 7–10 years of relevant pharmaceutical manufacturing QA/QC experience, a Bachelor's degree in a related field, and strong project management capabilities.