Job Title: Quality Engineer – External (Aseptic / Sterile Manufacturing)

Position Summary
This position is responsible for external Quality Assurance oversight, with a primary focus on sterile manufacturing and aseptic processing. The role ensures that CMOs, suppliers, and laboratories comply with FDA, EMA, and global cGMP requirements for sterile injectables.

This individual will play a critical role in supporting aseptic operations, regulatory inspections, and maintaining high standards of sterility assurance across external partners. Periodic domestic and international travel is expected; a valid passport is required

Key Responsibilities

GMP Compliance (Sterile CMOs/Suppliers)

• Ensure compliance with FDA, EMA, and global cGMPs specific to aseptic processing and sterile injectables
  

• Lead supplier qualification for sterile manufacturing sites
  

• Perform and support audits focused on aseptic filling, cleanroom operations, and contamination control strategies
  

• Maintain audit schedules and ensure inspection readiness
  

• Monitor regulatory updates related to sterile manufacturing (e.g., Annex 1)
  

• Support new product introductions involving sterile dosage forms

Expected Outcome:
Highly compliant sterile supplier network with strong inspection readiness

Quality Assurance Oversight

• Review and approve deviations, EM excursions, OOS/OOT results, and change controls
  

• Evaluate aseptic process performance and contamination control trends
  

• Track and verify effectiveness of corrective actions from audits
  

• Support management of Approved Supplier List (ASL)
  

• Ensure compliance with sterility assurance elements including validation, media fills, and environmental monitoring

Expected Outcome:
Strong sterility assurance and minimized contamination risk

Quality Planning & Continuous Improvement

• Support validation strategies (process validation, cleaning validation, aseptic media fills)
  

• Drive continuous improvement in contamination control and aseptic practices
  

• Collaborate with Regulatory, Clinical, and Quality Risk Management teams
  

• Support inspection readiness and host regulatory inspections when needed
  

• Present quality metrics and compliance risks to leadership

Expected Outcome:
Continuous improvement in sterile manufacturing compliance and audit outcomes

Qualifications

• Bachelor’s degree in Biology, Chemistry, Engineering, or related field
  

• Minimum 5+ years in pharmaceutical quality within sterile/aseptic manufacturing
  

• Strong knowledge of aseptic processing, Annex 1, and sterile GMP requirements
  

• Experience auditing sterile CMOs and supporting regulatory inspections
  

• Hands-on experience with environmental monitoring, media fills, and contamination control

Key Skills

• Deep expertise in aseptic processing and sterility assurance
  

• Strong auditing and inspection readiness experience
  

• Root cause analysis and risk management
  

• Ability to work cross-functionally in a global environment
  

• Strong communication and stakeholder management skills

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