Senior Compliance Advisor (Healthcare, Remote)

Job summary

The Senior Compliance Advisor will manage GxP impacting projects to ensure compliance with regulatory requirements for computerized systems. This role involves overseeing validation processes and ensuring systems meet user requirements and quality standards.

Qualifications

• Bachelor's degree in computer science, engineering, life sciences, or a related field.
• Minimum of 2 years of experience in equipment/process validation lifecycle management and validation documentation development.
• At least 2 years of experience in the pharmaceutical manufacturing or medical device industry focusing on computer systems validation, process validation, QA, or compliance functions.

Responsibilities

• Evaluate new computerized systems for GxP impact and guide risk-based validation approaches.
• Collaborate with project managers to meet compliance milestones throughout project lifecycles.
• Develop and review validation deliverables, including plans, protocols, specifications, and reports.
• Establish standards and training materials for computerized systems in alignment with regulations.
• Manage formal testing of systems and resolve validation process issues.
• Review changes to validated systems and ensure compliant documentation.
• Conduct quality reviews and maintain supplier assessments to ensure reliability.

Skills

• Strong engineering background with a focus on equipment/process validation.
• In-depth knowledge of GxP regulations and best practices (21CFR820, 21CFR11, Annex 11, GAMP).
• Experience with electronic software applications like EDMS, PLM, QMS, LIMS, and ERP.
• Excellent communication skills and ability to influence and negotiate effectively.
• Strong multitasking and prioritization abilities.

Tools

• Familiarity with validation documentation tools and electronic systems used in compliance management.