Description

You will manage IT quality systems and ensure all processes meet regulatory and quality requirements within an FDA-regulated environment.

Responsibilities

• Maintain IT processes and procedures to meet Quality System requirements and regulatory guidelines.
• Execute Quality Risk Management (QRM) principles during formal and informal risk assessment initiatives.
• Manage quality system records, including change controls, CAPAs, deviations, and data integrity initiatives.
• Support the Quality Auditing function regarding IT vendors, audits, and the Approved Supplier List (ASL) process.
• Collaborate with cross-functional teams to ensure new systems and software validation processes comply with SOPs and WIs.

Required Skills

• 7+ years of experience in IT, Computer Science, Engineering, or Chemistry within an FDA-regulated manufacturing environment.
• Thorough understanding of IT CSV and QA IT roles supporting GxP compliance.
• Deep knowledge of FDA CFRs, Euralex, and biotech/pharma industry regulations for IT, laboratory systems, and automation.
• Expertise in Data Integrity and System Development Life Cycle (SDLC) validation methodologies.
• Proven experience with deviation management, incident management, and change control.
• Practical application of root cause analysis and risk management techniques.
• Experience leading cross-functional projects in systems validation, such as laboratory equipment, manufacturing equipment, or information systems.

Preferred Skills

• Bachelor's degree in Life Science, Computer Science, Engineering, or Information Technology.

Key Skills

Education

Bachelor's degree