Manager, Quality Operations
Aquestive Therapeutics
August 29, 2026
On-site
Portage, IN
Operations
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.
Responsibilities:
- Provide real-time QA oversight of manufacturing and packaging (multi-site, multi-shift).
- Manage the product quality release program to ensure on-time results and adherence to internal procedures.
- Deliver real-time quality risk assessment/decision support, including containment and correction measures.
- Review and release batch records.
- Author, review, and/or approve quality documentation related to manufacturing.
- Ensure adherence to SOPs, batch records, and GMP requirements.
- Lead/oversee deviations, OOS, complaints, and investigations with robust root cause analysis and effective CAPAs.
- Manage Quality Operations personnel (priorities, staffing plans, shift coverage).
- Manage incoming materials quality review/approval for receipt, assessment, and release.
- Coach teams on GMP decision-making, risk-based quality judgment, and investigator rigor.
- Monitor and report key quality metrics (e.g., right first time).
- Identify trends and drive process improvements and simplification.
- Maintain audit readiness supporting health authority inspections and internal audits.
- Serve as a primary QA partner to Manufacturing, Quality Control, Supply Chain, and Quality Systems.
Qualifications:
- Bachelor’s degree (Science, Engineering, or related)
- ~7–10 years in GMP pharmaceutical manufacturing QA/QC
- Prior people management or strong informal leadership
Skills/Expertise:
- cGMP regulations (FDA/EU)
- Quality systems (CAPA, deviations, change control)
- Manufacturing and/or QC operations
- Proficient computer skills (e.g., Microsoft Word, Excel, Access, PowerPoint, Visio)
- Strong project management and organizational skills
- Strong business acumen in pharmaceutical manufacturing
- Some travel required
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.
Responsibilities:
- Provide real-time QA oversight of manufacturing and packaging (multi-site, multi-shift).
- Manage the product quality release program to ensure on-time results and adherence to internal procedures.
- Deliver real-time quality risk assessment/decision support, including containment and correction measures.
- Review and release batch records.
- Author, review, and/or approve quality documentation related to manufacturing.
- Ensure adherence to SOPs, batch records, and GMP requirements.
- Lead/oversee deviations, OOS, complaints, and investigations with robust root cause analysis and effective CAPAs.
- Manage Quality Operations personnel (priorities, staffing plans, shift coverage).
- Manage incoming materials quality review/approval for receipt, assessment, and release.
- Coach teams on GMP decision-making, risk-based quality judgment, and investigator rigor.
- Monitor and report key quality metrics (e.g., right first time).
- Identify trends and drive process improvements and simplification.
- Maintain audit readiness supporting health authority inspections and internal audits.
- Serve as a primary QA partner to Manufacturing, Quality Control, Supply Chain, and Quality Systems.
Qualifications:
- Bachelor’s degree (Science, Engineering, or related)
- ~7–10 years in GMP pharmaceutical manufacturing QA/QC
- Prior people management or strong informal leadership
Skills/Expertise:
- cGMP regulations (FDA/EU)
- Quality systems (CAPA, deviations, change control)
- Manufacturing and/or QC operations
- Proficient computer skills (e.g., Microsoft Word, Excel, Access, PowerPoint, Visio)
- Strong project management and organizational skills
- Strong business acumen in pharmaceutical manufacturing
- Some travel required