Compliance Manager

Job Description:

Role SummaryPlans, conducts, reports, and follows up on assigned computer system audits of third parties, processes, and internal systems. Also participates in joint audits with GCP/GLP/GxP auditors, bringing computer system compliance expertise.Key Responsibilities:

• Plan and perform risk-based audits of vendors, suppliers, internal GxP computer systems, and supporting processes.
• Assess whether computer systems and data integrity controls meet applicable regulations (e.g., 21 CFR Part 11, EU Annex 11, GAMP 5) and GSK policies.
• Prepare clear, timely audit reports; classify and communicate findings and risks to auditees and stakeholders.
• Review CAPA plans, verify effective implementation, and escalate overdue or high-risk issues.
• Partner with GxP auditors on joint audits, contributing computer compliance expertise.
• Support regulatory inspection readiness and respond to high-priority compliance issues as assigned.
• Keep abreast of regulatory changes and flag emerging computer compliance risks to the team.
• Maintain accurate audit records and meet assigned schedules in line with QA procedures.

Required Skills & Experience:

• Working knowledge of GxP computer system compliance regulations and industry expectations (CSV, data integrity, risk-based validation).
• Proven experience conducting audits in a regulated pharmaceutical or life sciences setting.
• Ability to look beyond pure compliance to broader, cross-GxP risks.
• Clear, concise written and verbal communication; able to simplify complex technical topics for varied audiences.
• Skilled at influencing and negotiating with stakeholders internally and externally.
• Able to work independently and manage multiple audits and deadlines.

Desirable:

• Experience hosting or supporting regulatory inspections.
• Auditor qualification or certification (e.g., ASQ CQA, CSQE, or equivalent).