Manager, Quality Operations

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

Job Summary

Responsible for leading day-to-day quality oversight of manufacturing and operational activities to ensure compliance with cGMP, regulatory requirements, and company quality systems. Drives execution, inspection readiness, and continuous improvement across quality operations.

This position will be expected to work in a highly collaborative, cross functional team environment, and provide expert knowledge to risk identification/mitigation, strategy and execution.

Responsibilities

• Daily GMP Oversight (Shop Floor + Operations), providing real-time QA oversight of manufacturing and packaging activities of a multi-site, multi-shift operation.
• Manage the product quality release program, ensuring on-time results and adherence to internal procedures.
• Provide quality risk assessment and decision support real-time, including containment correction measures.
• Review and release of batch records.
• Author, review and/or approve quality documentation related to manufacturing.
• Ensure adherence to SOPs, batch records, and GMP requirements
• Lead and/or oversee deviations, OOS, complaints, and investigations, ensuring robust root cause analysis and effective CAPAs.
• Manage Quality Operations personnel, setting priorities, staffing plans and shift coverage.
• Manage incoming materials quality review/approval to ensure materials are appropriately received, assessed, and released for use in accordance with applicable procedures.
• Coach team on GMP decision-making, risk-based quality judgement and investigator rigor.
• Monitor and report key quality metrics, including right first time.
• Identify trends and drive process improvements and simplification.
• Ensure continuous state of audit readiness, supporting health authority inspections and internal audits.
• Act as a primary QA partner to Manufacturing, Quality Control and Supply Chain and Quality Systems.

Qualifications

• Education: Bachelor’s degree (Science, Engineering, or related)
• Experience: ~7–10 years in GMP pharmaceutical manufacturing QA/QC
• Leadership: Prior people management or strong informal leadership
• Expertise:
  • cGMP regulations (FDA / EU)
  • Quality systems (CAPA, deviations, change control)
  • Manufacturing and/or QC operations
• Excellent computer skills required (e.g., Microsoft Word, Excel, Access, PowerPoint, Visio).
• Strong project management skills, strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on time and on budget.
• Strong business acumen surrounding pharmaceutical manufacturing.
• Some travel required.

Aquestive provides equal employment opportunities to all colleagues and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.