Description

You will manage quality system activities and document control during QMS integration and system migration phases.

Responsibilities

• Oversee Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.
• Support legacy Quality systems and manual processes during transitions to new digital platforms.
• Manage the GxP Training Program by delivering training on topics such as GMP, Change Control, Deviation, and CAPA.
• Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely compliance of quality records.
• Generate and trend quality metrics to communicate findings to leadership.
• Assist in the creation, revision, and periodic review of SOPs, policies, forms, and templates.
• Support internal and external regulatory audits and execute corrective action plans.

Required Skills

• 8+ years of experience in a GxP environment, preferably in pharmaceutical, biotech, or cell/gene therapy manufacturing.
• Deep knowledge of Quality Management Systems in a cGxP manufacturing environment.
• Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
• Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS).
• Experience using ComplianceWire (LMS) and Qualio (EDMS).
• Advanced proficiency in Microsoft Office Suite, specifically Excel, PowerPoint, and Word.
• Proven ability to write and revise SOPs, work instructions, and Quality System documents.
• Experience developing and delivering training materials to employees.
• Bachelor's degree in Life Sciences or a related discipline.

Key Skills

Education

Bachelor's degree