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The core of Compliance Architects’ best-in-class talent offerings is our proprietary, innovative life sciences quality skills inventory . Assessing competence in over 225 skill and capability areas, our skills inventory helps us ensure we provide only the most outstanding consultants for your complex quality, regulatory, compliance and operations needs. Want some additional detail on how we do it? Let us know and we’ll walk you through our approach and show you how it drives best fit-to-need in the industry.

Senior consulting expert in compliance, quality (GMP, GLP, GCP), and regulatory affairs.

Recent client projects:

• Evaluate and assess global QMS document architectures and hierarchies; implement effective re-structuring to improve compliance and execution through simplified processes and procedures.

• Inspection preparation, support through inspections, write responses to various regulatory actions including 483s, Warning Letters, and Consent Decrees.

• Develop manufacturing processes and checklists for Quality oversight for a Client operating under a Warning Letter status.

• Lead a multi-year Quality Management System (QMS) improvement project for several large global pharmaceutical companies, which included strategic planning and execution of enhancing 20+ Quality Systems from in process, governance, and technology.

• Lead the configuration and design of a new enterprise document management system, Veeva Vault QualityDocs, supporting a global manufacturing operation.

Expert at:

pharmaceuticals, OTC, dietary supplements, batch records, CAPA, laboratory controls, QA, SOP development, training program development.

Highly skilled at:

analytical chemistry, QC, quality system design, stability programs, mentoring.

QMS/Strategy consultant with expertise in medical device and pharmaceuticals, quality assurance, quality system design/ development.

Recent client projects:

• Remediation activities at a large device company under Warning Letter.

• Migration of documentation management system with all documents to new electronic platform for a company spin-off. • Assessment of drug firm’s quality system, submission strategies, and reporting requirements to assist them in their transition to device development.

• De novo development of a quality system for a medical device company.•Interim Quality Head.

Expert at:

medical devices, 483 and Warning Letter responses, audits/assessments, compliance strategy, FDA inspection management, complaints/MDRs, CAPA and deviations, device design controls, ISO 13485, laboratory controls, quality system design, risk analysis and management, supplier management & controls, IVDs, medical device software.

Highly skilled at:

pharmaceuticals, drug/device combination products, cosmetics, pre-market approvals, FMEAs, quality control, validation, mock inspections.

Senior quality systems expert with engineering experience with formulated and combination medical device product quality from concept to commercialization.

Recent client projects:

• QMS Document Hierarchy Assessment - assess QMS procedural documents used by Stability QC Labs and develop a proposal to consolidate documents into logical hierarchy.

• Gap assessment - perform an assessment of gaps and changes required to bring a QMS into compliance with ISO 13485:2016; to comply with EU IVD and MDR regulations; and to align with scope of client business model.

Expert at:

medical devices, DHF, DMR, DMF, CAPA/deviations/NCs, quality engineering, quality system design, risk analysis and management, technical transfer.

Highly skilled at:

combination products, batch records, medical device software, equipment qualification, SOP development, QC, supplier management controls, training development.

Results-driven quality management consultant and industry expert who translates vision and strategy into customer-oriented actions.

Recent client projects:

•Consulting, training, and audit support to achieve compliance with US FDA and global regulations

•Interim VP of quality

Expert at:

medical Devices, IVDs, implantables, quality system remediation, CAPA, complaints, MDR, MDV, device design controls, FDA inspection preparation and management, lean compliance, SOP design and development.

Highly skilled at:

pharmaceuticals, cosmetics, process optimization, quality system audits, verification and validation, mock inspections, due diligence.

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