Senior Consultant – Compliance Services

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🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

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CREO

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2015

💼 Consulting

🏥 Healthcare

Consulting • Healthcare • Life Sciences

CREO is a management consulting and advisory firm specializing in the life sciences and healthcare sectors. The company collaborates with leading life sciences and healthcare organizations to foster innovation in human health. By providing services in strategy development, M&A, product launch, digital transformation, cybersecurity, and IT compliance, CREO aims to unlock the growth potential of its clients. The firm is recognized for its holistic approach, which integrates growth management, people development, and technology to help companies navigate complex challenges and achieve their business objectives. CREO is committed to driving tangible value and advancing science through its expert consulting solutions.

📋 Description

• Lead client engagements involving the design, implementation, remediation, and optimization of Quality Management Systems for CROs, Sponsors, and life sciences organizations • Serve as a primary client contact and facilitate stakeholder workshops and interviews • 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 quality expectations • Maintain personal billable utilization of 1700 hours per year • Develop and implement scalable, risk-based, end-to-end QMS frameworks • Author, revise, and review Quality Manuals, Quality Plans, policies, SOPs, Work Instructions, forms, templates, and governance documents • Establish or improve document control, training, deviation and quality event management, CAPA, change control, supplier quality, and management review processes • Develop quality metrics, KPIs, governance routines, escalation pathways, and continuous improvement programs • Support risk-based quality management aligned with GCP, ICH guidance, and regulatory expectations • Plan and perform QMS maturity assessments, regulatory gap analyses, internal audits, vendor/service provider audits, qualification audits, and mock inspections • Assess quality processes, procedures, records, training programs, governance, data integrity controls, and quality oversight mechanisms • Prepare 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 • Translate regulatory and quality requirements into pragmatic recommendations supporting compliance and business objectives • Lead 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 improvement opportunities • 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 and identify quality and compliance opportunities • Develop proposals, Statements of Work, project approaches, and level-of-effort estimates • Contribute to thought leadership, reusable methods, templates, and service offerings

🎯 Requirements

• 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 Life Sciences, Quality, Engineering, Regulatory Affairs, Public Health, or a related field • Experience establishing, implementing, significantly enhancing, or remediating a Quality Management System • 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 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 • Ability to independently lead complex client workstreams, manage multiple priorities, and deliver high-quality work with limited supervision • Experience mentoring junior staff and collaborating with cross-functional client teams • Exceptional written and verbal communication skills, including presenting complex quality and compliance concepts to senior-level stakeholders • Strong analytical, facilitation, problem-solving, and project management skills • Ability to travel based on client and project needs • Preferred: experience supporting regulatory inspections, sponsor audits, or formal inspection readiness programs • Preferred: experience with eQMS, clinical technology platforms, or quality data and reporting tools • Preferred: experience across GMP, GLP, GVP, or computerized system compliance • Preferred: professional certification such as ASQ Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, RQAP, RAC, PMP, or equivalent • Preferred: advanced degree in a relevant discipline

🏖️ Benefits

• Travel based on client and project needs • Professional certification opportunities/recognition, including ASQ Certified Quality Auditor, ASQ Certified Manager of Quality/Organizational Excellence, RQAP, RAC, PMP, or equivalent (preferred qualifications) • Potential use of electronic Quality Management Systems, clinical technology platforms, and quality data/reporting tools • Professional development through mentoring junior team members, thought leadership, reusable methods, templates, and service offerings

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