[Hiring] Senior Consultant - Compliance Services @CREO

Role Description

CREO Senior Consultants in Compliance Services serve as trusted advisors to Clinical Research Organizations (CROs), Sponsors, and life sciences companies seeking to establish, enhance, remediate, and maintain compliant quality systems. This role leads complex quality and compliance engagements and helps clients build scalable quality frameworks that support clinical research and development activities while meeting applicable global regulatory expectations.

Senior Consultants are highly motivated, self-directed professionals with strong quality, analytical, project leadership, and communication skills. In this role, you will independently manage client workstreams, lead QMS assessments and audits, develop client-ready quality documentation, translate regulatory expectations into practical business solutions, and mentor junior team members.

This role will serve clients nationally and may require travel based on client and project needs.

Qualifications

• 8+ years of Quality Assurance, Quality Systems, regulatory compliance, clinical research, or consulting experience within CRO, pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
• Bachelor's degree in a relevant field.
• Demonstrated experience establishing, implementing, significantly enhancing, or remediating a Quality Management System, preferably within a CRO or clinical research environment.
• Experience conducting QMS audits, internal audits, supplier or vendor audits, gap assessments, and compliance evaluations.
• Working knowledge of Good Clinical Practice (GCP), quality risk management, CAPA, change control, deviation and quality event management, document control, training, supplier quality, and management review.
• Knowledge of applicable regulations, standards, and guidance, including relevant FDA regulations, ICH E6 R3, ISO 9001, ISO 13485, and global health authority expectations.
• Experience developing quality system documentation, audit and assessment reports, remediation plans, quality metrics, and executive-level deliverables.
• Proven ability to independently lead complex client workstreams, manage multiple priorities, and deliver high-quality work with limited supervision.
• Leadership skills with experience mentoring junior staff and collaborating effectively with cross-functional client teams.
• Exceptional written and verbal communication skills, including the ability to present complex quality and compliance concepts to senior-level stakeholders.
• Strong analytical, facilitation, problem-solving, and project management skills.
• Bachelor's degree in Life Sciences, Quality, Engineering, Regulatory Affairs, Public Health, or a related field.
• Ability to travel based on client and project needs.

Requirements

• 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.

Benefits

• Maintain personal billable utilization at the rate of 1700 hours per year.
• Achieve annual sales targets as communicated separately.
• Identify quality and compliance opportunities within existing client relationships and support development of new client relationships.
• Develop proposals, Statements of Work, project approaches, and level-of-effort estimates for QMS and quality consulting engagements.
• Contribute to thought leadership, reusable methods, templates, and service offerings within CREO's Quality and Compliance practice.
• Foster relationships with Quality, Clinical, Regulatory, and executive stakeholders across the life sciences industry.

Company Description

Please note: This application may be reviewed in part by automated systems to help identify qualified candidates.