QA Aseptic Principal

QA Aseptic Principal Job Summary

Join our dynamic Quality Assurance team as a senior technical leader who will shape the future of aseptic manufacturing excellence at INCOG! This is an exceptional opportunity for an experienced QA professional to become the subject matter expert on aseptic processes, contamination control, and regulatory compliance in a fast‑growing CDMO environment. You'll work alongside a collaborative team of quality professionals who are passionate about ensuring patient safety while supporting our clients' success in bringing life‑saving therapies to market.

• Aseptic Process Oversight:
  Provide quality assurance oversight and approval for all media fills, aseptic setup procedures for isolators, and aseptic process validations to ensure compliance with cGMP requirements; develop and improve system reporting documents and system improvements to support multi‑product, multi‑client manufacturing operations.
• Contamination Control Leadership:
  Develop, implement, and maintain comprehensive contamination control strategies using risk‑based methodology across sterile manufacturing operations. Lead multi‑functional risk assessment and other technical exercises to assess and improve aseptic conditions and operations.
• Environmental Monitoring Program Management:
  Review and approve quarterly environmental monitoring reports, trend analysis, and investigation of excursions to ensure continuous improvement of aseptic conditions.
• Aseptic Intervention Guidance:
  Serve as the technical authority for evaluating and approving aseptic interventions, including risk assessments, corrective actions, and impact evaluations on product sterility assurance.
• Training and Development:
  Design and deliver comprehensive training programs for manufacturing floor personnel and QA staff on aseptic technique, contamination control principles, and regulatory requirements; assess on‑floor trainers' expertise and support the training and assessments of floor operations and operators.
• Subject Matter Expertise:
  Function as the primary SME on aseptic manufacturing risks, providing technical guidance on complex sterility assurance challenges and emerging regulatory trends.
• Regulatory and Client Interface:
  Represent INCOG's aseptic systems and controls during FDA, EMA, and client audits, providing technical presentations and responding to regulatory inquiries. Serve as the primary respondent to client and regulatory audits for aseptic topics.
• Regulatory Compliance Assurance:
  Ensure all aseptic controls and contamination control measures meet current FDA, EMA, ICH, and other applicable guidance documents and regulations.
• Proactive Regulatory Intelligence:
  Monitor and analyze FDA and EMA observations, warning letters, and guidance updates to implement preventive measures and maintain competitive regulatory positioning.

• Bachelor's degree in Microbiology, Biology, Chemistry, Chemical Engineering, or related scientific discipline.
• Minimum 10 years of experience in pharmaceutical manufacturing with at least 8 years focused on aseptic manufacturing and sterile drug product operations.
• Minimum 7 years of Quality Assurance experience with media fills, environmental monitoring programs, and contamination control in a cGMP environment; proven technical leadership through FDA responses and new product introduction.
• Previous experience as a subject matter expert or technical lead in aseptic operations.
• Demonstrated experience with FDA and/or EMA inspections and regulatory interactions.
• Experience with client audits and technical presentations to external stakeholders.
• Demonstrated experience in aseptic operations optimization and improvements, including Annex 1 remediations and ensuring compliance.
• Strong knowledge of USP, FDA Guidance for Industry on Sterile Drug Products, and EU GMP Annex 1.
• Experience with isolator technology, RABS (Restricted Access Barrier Systems), and aseptic fill‑finish operations.
• Proven track record in training development and delivery for technical topics.
• Excellent written and verbal communication skills with ability to present to senior management, clients, and…