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.
• Minimum of 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 oversee validation deliverables including Validation Plans, Test Plans, Compliance Assessments, and Validation Reports.
• Review and approve major system documentation for quality consistency.
• Coach implementation teams on validation document execution.
• Manage formal testing of computerized systems and resolve validation process issues.
• Review changes to validated systems and ensure compliant documentation.
• Conduct Quality Reviews to identify process deficiencies and improvement opportunities.

Skills

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

Tools

• Familiarity with Electronic Document Management Systems (EDMS), Product Lifecycle Management (PLM), Quality Management Systems (QMS), Laboratory Information Systems (LIMS), and Enterprise Resource Planning (ERP) systems.