Quality & Compliance Consultant

About the role

ProductLife Group is seeking an experienced Quality & Compliance Consultant to support client projects in the life sciences sector. You will work on quality management systems, GxP compliance, and continuous improvement initiatives, delivering impactful solutions for pharmaceutical, biotech, and medical device organizations.

Key responsibilities

• Support client projects involving QMS, GxP compliance, quality operations, and continuous improvement.
• Assess processes, documentation, and workflows to identify gaps, risks, and improvement opportunities.
• Develop, review, and maintain SOPs, work instructions, quality plans, process maps, and controlled documentation.
• Manage quality system activities such as deviations, CAPA, change control, document control, training, and non‑conformance investigations.
• Assist with audits, mock inspections, inspection readiness, and corrective‑preventive action tracking.
• Collect, analyze, and report quality metrics, KPIs, and compliance trends.
• Prepare client deliverables including assessments, gap analyses, reports, dashboards, and executive summaries.
• Participate in process‑mapping workshops, stakeholder interviews, and cross‑functional meetings.
• Manage project tasks, timelines, risks, and dependencies, escalating issues as needed.

Required profile

• Bachelor’s degree in a life‑science or related scientific discipline.
• 5‑7+ years of experience in Quality Assurance, Quality Systems, Compliance, or related life‑science fields.
• Experience in pharmaceutical, biotechnology, medical device, CRO, CDMO, or consulting environments.
• Proven ability to independently manage workstreams and deliver high‑quality project outcomes.

Required skills

• GxP compliance
• Quality Management System (QMS) implementation
• CAPA management
• Change control
• Document control
• Audit support and inspection readiness
• Process mapping
• Regulatory research
• Lean Six Sigma methodology
• Project management