Change Control & Deviation Management Lead

Position Responsibilities

• Establish and maintain robust systems for Change Control and Deviation Management, in alignment with the our Manufacturing Division Quality Management System (QMS), for the Wilmington Biotech site.
• Manage and monitor the processes for the site, including but not limited to, providing guidance and support to Change/Deviation Owners, review the Change Management System dashboard, escalate Changes/Deviations with potential risk(s) accordingly, track and trend Deviations.
• Serve as site Subject Matter Expert (SME) for the deviation management and change control system.
• Monitor performance of the site change control and deviation management system, providing structure for performance monitoring across the site teams.
• Support compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements for Change Control and Deviation Management.
• Provide Change Control and Deviation Management information necessary for the Annual Product Quality Review (APQR), as applicable and appropriate.
• Responsible for provision of Change Control and Deviation Management metrics in relation to the Quality Council process.
• Serve as site topic lead for deviation management and change control and provide training to end users.
• Take part in the Change Control and Deviation Management communities of practice/knowledge networks.
• Support external CGMP audits (e.g., Regulatory Authorities, Global Quality) as SME in Change Control and Deviation Management.
• Knowledge of US and European GMP guidelines, ICH, and other international regulatory requirements, as applicable to the site.

Qualifications & Experience

• Minimum of 5 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
• Contemporary knowledge of relevant CGMPs, regulations, and current industry trends.
• Operational experience in Change Control and Deviation Management.
• Knowledge of global health authority regulations and quality and compliance requirements with the ability to effectively communicate these requirements.
• Industry Best Practices for quality and compliance related topics.
• Strong collaboration and cross-functional skills to support continuous improvement, promote knowledge sharing, and implement best practices across the site and Compliance functions on global and local levels.
• Strong verbal and written communication skills, as well as project management skills.
• Demonstrated ability to influence areas not under direct control to maintain compliance with the requirements of the Change Control and Deviation Management systems.
• Demonstrated ability to make and act on decisions while balancing speed, quality, and risk.
• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering, or equivalent.
• Direct experience in manufacture of antibody drug conjugates and/or sterile manufacturing preferred.