Senior Consultant- Compliance Services

JOB DESCRIPTION OVERVIEW 

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. 

• Lead client engagements focused on the design, implementation, remediation, and optimization of Quality Management Systems for CROs, Sponsors, and other life sciences organizations. 

• Serve as a primary client contact, facilitate stakeholder workshops and interviews, and manage project scope, timelines, risks, deliverables, and client expectations. 

• Collaborate with Quality Assurance, Clinical Operations, Regulatory Affairs, Data Management, Pharmacovigilance, Vendor Management, and other client functions. 

• Manage and mentor junior team members and ensure work products meet CREO and client quality expectations. 

• Maintain personal billable utilization at the rate of 1700 hours per year. 

2. Design, implement, and remediate Quality Management Systems 

• Develop and implement end-to-end QMS frameworks that are scalable, risk-based, and appropriate for the client organization and operating model. 

• Author, revise, and review Quality Manuals, Quality Plans, policies, Standard Operating Procedures (SOPs), Work Instructions, forms, templates, and associated governance documents. 

• Establish or improve document control, training, deviation and quality event management, Corrective and Preventive Action (CAPA), change control, supplier quality, and management review processes. 

• Develop quality metrics, Key Performance Indicators (KPIs), governance routines, escalation pathways, and continuous improvement programs. 

• Support risk-based quality management approaches aligned with Good Clinical Practice (GCP), ICH guidance, and applicable regulatory expectations. 

3. Conduct QMS audits, gap assessments, and compliance evaluations

• Plan and perform QMS maturity assessments, regulatory gap analyses, internal audits, vendor and service provider audits, qualification audits, and mock inspections. 

• Assess quality system processes, procedures, records, training programs, governance, data integrity controls, and quality oversight mechanisms. 

• Prepare clear, client-ready audit reports, assessment reports, observations, risk ratings, remediation roadmaps, and executive presentations. 

• Support root cause analysis, CAPA development, remediation planning, effectiveness checks, and inspection readiness activities. 

• Evaluate compliance with applicable requirements and standards, which may include FDA regulations, ICH E6 Good Clinical Practice, ISO 9001, ISO 13485, and relevant global health authority expectations. 
   

4, Deliver quality and compliance advisory services 

• Translate complex regulatory and quality requirements into pragmatic recommendations that support both compliance and business objectives. 

• Lead development of quality strategies, operating models, implementation plans, governance structures, training materials, and sustainable process improvements. 

• Analyze quality metrics and operational performance to identify trends, risks, and opportunities for improvement. 

• Present findings, recommendations, and implementation priorities to client executives and senior stakeholders. 

• Develop and deliver training related to QMS fundamentals, GCP quality, quality risk management, CAPA, auditing, supplier quality, and inspection readiness. 

• 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. 
   

REQUIRED QUALIFICATIONS, SKILLS, AND EXPERIENCE 

• 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. 

PREFERRED QUALIFICATIONS

• Experience supporting regulatory inspections, sponsor audits, or formal inspection readiness programs. 

• Experience with electronic Quality Management Systems (eQMS), clinical technology platforms, or quality data and reporting tools. 

• Experience across additional GxP domains such as GMP, GLP, GVP, or computerized system compliance. 

• Professional certification such as ASQ Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, RQAP, RAC, PMP, or equivalent. 

• Advanced degree in a relevant discipline.