Senior QMS & Compliance Consultant for Life Sciences

Creo Inc; United States; Remote; USD 150,000 - 220,000; Full time

Job summary

Creo Inc. is seeking a Senior Consultant in Compliance Services to lead complex quality engagements for CROs, sponsors, and life sciences companies.

You will design scalable QMS frameworks, author governance documents, and mentor junior staff while ensuring alignment with GCP, FDA, ICH, and ISO standards. Travel may be required for client engagements; you will manage client expectations, lead workshops, and deliver executives with strategic quality recommendations that drive continuous

Qualifications

• 8+ years of QA, QMS, regulatory compliance, or consulting in life sciences.
• Bachelor's degree in a relevant field.
• Experience establishing or remediating a QMS, preferably in CRO/clinical research.
• Experience conducting QMS audits and compliance evaluations.
• Knowledge of FDA regulations, ICH E6, ISO 9001, ISO 13485, and global health authority expectations.
• Ability to independently lead complex client workstreams.
• Leadership and mentoring of junior staff.
• Excellent written and verbal communication skills.
• Willingness to travel based on client needs.

Responsibilities

• Lead and manage QMS consulting engagements.
• Design, implement, and remediate Quality Management Systems.
• Conduct QMS audits, gap assessments, and compliance evaluations.
• Deliver quality and compliance advisory services.
• Contribute to business development.

Skills

Quality assurance

Communication skills

Project leadership

Analytical skills

Mentoring

Education

Bachelor's degree (relevant field)

Bachelor's degree in Life Sciences/Quality/Engineering/Regulatory Affairs/Public Health

Tools

eQMS

Clinical technology platforms

Quality data & reporting tools

Job description

Creo Inc. is seeking a Senior Consultant in Compliance Services to lead complex quality engagements for CROs, sponsors, and life sciences companies.

You will design scalable QMS frameworks, author governance documents, and mentor junior staff while ensuring alignment with GCP, FDA, ICH, and ISO standards. Travel may be required for client engagements; you will manage client expectations, lead workshops, and deliver executives with strategic quality recommendations that drive continuous