Senior QMS Consultant - Life Sciences Compliance

Creo Inc; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Creo Inc. is seeking a senior consultant to lead quality management system engagements for CROs, sponsors, and life sciences clients. You will design, implement, and remediate scalable QMS frameworks while meeting global regulatory expectations.

You will independently manage client workstreams, perform audits, prepare reports, and mentor junior staff. Travel may be required based on client needs.

Qualifications

• Minimum 8+ years in QA, quality systems, regulatory compliance, or consulting in life sciences.
• Bachelor's degree in a relevant field; advanced degree preferred.
• Experience designing and improving QMS for CROs or clinical research environments.
• Strong knowledge of GCP, CAPA, change control, and documentation control.

Responsibilities

• Lead and manage QMS consulting engagements for clients in life sciences.
• Design, implement, and remediate scalable QMS frameworks and governance.
• Conduct QMS audits, gap assessments, and regulatory evaluations for clients.
• Develop client-ready quality documents, reports, and executive presentations.
• Mentor junior team members and manage multiple client workstreams.

Skills

Quality Assurance

Quality Systems

Regulatory compliance

Clinical research

Project leadership

Client management

Mentoring

Communication

GCP knowledge

Audits

Education

Bachelor's degree

Advanced degree

Job description

Creo Inc. is seeking a senior consultant to lead quality management system engagements for CROs, sponsors, and life sciences clients. You will design, implement, and remediate scalable QMS frameworks while meeting global regulatory expectations.

You will independently manage client workstreams, perform audits, prepare reports, and mentor junior staff. Travel may be required based on client needs.