Senior Quality & Compliance Consultant - Life Sciences

ProductLife Group; United States; On-site; USD 125,000 - 145,000; Full time

Job summary

ProductLife Group is seeking an experienced Quality Consultant to join our growing team in the life sciences sector. You will support QMS, GxP compliance, quality operations, and continuous improvement initiatives across client projects.

You will assess processes, develop SOPs and quality documentation, manage CAPA and deviations, and contribute to audits, inspections, and performance dashboards. Strong writing and project coordination are essential.

Qualifications

• Bachelor's degree in life sciences or related field.
• Advanced degree or certification in quality/regulatory/PM or Lean Six Sigma preferred.
• Experience in life sciences quality and regulatory environments.

Responsibilities

• Support client projects involving QMS, GxP compliance, quality operations, and continuous improvement initiatives.
• Assess processes and documentation to identify compliance gaps, risks, and improvement opportunities.
• Develop, review, and maintain SOPs, work instructions, quality plans, and quality records.
• Support quality system activities including deviations, CAPA, change control, document control, training management, and nonconformance investigations.
• Participate in implementation and continuous improvement of QMS and regulatory compliance.
• Assist audits, mock inspections, inspection readiness activities, and tracking CAPA actions.
• Collect and report quality metrics, KPIs, and compliance trends for decision-making.
• Prepare client deliverables like assessments, gap analyses, reports, dashboards, and executive summaries.

Education

Bachelor's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering, Quality, Regulatory Affairs, Clinical Research, or a related scientific discipline

Advanced degree and/or relevant quality, regulatory, project management, Lean Six Sigma, or continuous improvement certification

Tools

eQMS

LMS

Document management systems

Job description

ProductLife Group is seeking an experienced Quality Consultant to join our growing team in the life sciences sector. You will support QMS, GxP compliance, quality operations, and continuous improvement initiatives across client projects.

You will assess processes, develop SOPs and quality documentation, manage CAPA and deviations, and contribute to audits, inspections, and performance dashboards. Strong writing and project coordination are essential.