Live Virus Vaccine Quality Operations Lead

The Associate Director is responsible for Quality oversight of vaccine formulation and filling operations as well as the associated Quality Systems, and manages a team of Quality Specialists.

Primary Activities

• Directly leads activities in the execution of quality system functions relating to GMP compliance; champions multi-department teams regarding compliance initiatives and assessments.
• Coordinates and directs a team of multi-disciplined professionals in areas of process and systems supporting and enhancing the quality system(s).
• Ensure personnel operate within established policies/procedures and in compliance with cGMPs and all applicable government regulations; responsible for hiring and ensuring personnel are trained and performing per expectations.
• Manage and coach the Quality team (direct and indirect reports) to deliver strong results while developing individual and team capabilities.
• Ensure all team members operate safely and comply with established safety and environmental policies and procedures.
• Serve on local and site governance committees, including IPT and End to End Leadership Teams, Technical/Operations Reviews, and regulatory forums as well as strategic initiatives.
• Acquire and maintain technical process knowledge relevant to operations and testing; ensure documentation and products comply with applicable standards, procedures, and governing regulations.
• Proactively partner to identify and implement continuous improvement actions and corrective/preventative actions, reducing deviations, reducing lead-time, improving safety and eliminating waste while maintaining compliance.
• Review and approve deviations, corrective/preventative actions, commitments, change requests, and other Quality documents.

Minimum Education and Experience

Bachelor's Degree in Science, Engineering, or another technical field with eight (8) years' experience in a functional area such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain OR Master's degree in Science, Engineering, or another technical field with six (6) years' experience in a functional area such as Operations, Quality, Technical Operations, Technology, Engineering, Maintenance, and/or Supply Chain.

Required Experience and Skills

• Minimum two (2) concurrent years' experience managing direct reports.
• Strong understanding of CGMPs, FDA, and EMEA regulatory standards and strong compliance mindset.
• Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.

Preferred Experience and Skills

• Creating and sustaining a culture where compliance (Safety, Environment, cGMP) is an imperative.
• Establishing a Right First-Time culture by reducing waste and driving continuous improvement.
• Authoring, reviewing and/or approving compliance documents.
• Achieving compliance goals through a risk-based approach with deep understanding of GMP and EHS compliance and compliance risk.
• Excellent interpersonal, communication, collaboration, and negotiation skills.
• Deep knowledge and expertise in production operations to drive results and business outcomes.
• Experience interacting with site, divisional or regulatory audits.
• Creating an engaged workforce using Inclusion as the How.
• Knowledge of High Performing Organization tools and methodology, including MPS/lean processing and Inclusion.
• MPS experience - LSS Green Belt certification or equivalent experience.
• Talent Management including leading and mentoring.
• Proven ability to manage multiple projects simultaneously.
• Aseptic/sterile processing experience.
• Quality or Operations experience in Pharmaceutical, Biologics, Vaccines, or Therapeutic Protein manufacturing.