Nicole Lawrence

As a Sr. Associate in our Life Sciences Operations team, I look forward to leveraging my ten years of experience in life science quality assurance, compliance, regulatory affairs, operational excellence, and project management with my clients. Prior to joining the firm, I obtained significant experience within the pharmaceutical industry leading a variety of projects focused on compliance initiatives, six sigma, regulatory strategy, operational process change and improvement, and change management.

As a globally minded, strategic business leader with expertise in Fortune 500 Life Science Companies, I strive for and ensure the highest quality and deepest commitment to my work, and look forwarding to leveraging my prior experience and expertise to ensure success for your organization.

Engagement and Industry Experience:

• Conducted Regulatory Affairs support for global product registrations for Medical Device, Pharmaceutical and OTC products resulting from Fortune 500 Life Science client divestiture and organizational name change.
• Performed as project manager for Regulatory Information Management (RIM) System implementation. Managed Product and Lifecycle Registrations - Safety, Marketing Status, Baseline Indications, Submissions and CMC Data Migration business processes owners for use of the system.
• Performed cross-functional leadership and continuous process improvements, Audits, CAPA, SOPs, and regulatory document approval; internally and suppliers across all product lines and franchises for Toxicology, Clinical Research Operations, Regulatory Affairs, Formulation Development, Packaging, Engineering, Computer System Validation, Pilot Manufacturing, and Analytical/ Stability for compliance to internal corporate standards, ICH, FDA GMP, GCP, ISO for Fortune 100 Pharmaceutical Company.
• Expanded R&D Quality and Compliance focus from domestic to global compliance as business unit expanded globally. Led ICH gap assessment and requirement review meetings with management. Resulting in changes to the stability program, protocol design and data evaluation, clinical operations, analytical method development and other SOPs.
• Saved R&D $0.4M in cost structure efficiencies, 20% increase in right first-time documentation (60%-80%) and reduction in QA review cycle times through leading a sigma project team and implementing quality standards, prioritization, process flow charts, and metrics.
• Collaborated in establishing multimillion-dollar onsite Consumer Innovation Center (Market Research/ Clinical Research Site). Defined business processes such as clinical protocol development and reporting, deviation management, informed consent and adverse events through SOP development and approval.
• Collaborated on global product development teams to facilitate timelines for internal and outsourced third-party projects to support the product launch, across brands and product categories. QA project manager for clinical supplies production for Fortune 500 Pharmaceutical Company.
• Managed QA production projects to ensure completion of testing, appropriate raw materials, documented deviations resolved for all batch records prior to QA release and timely transfer to the pharmacy for distribution for top tier pediatric cancer research center.
• Defined audit program as Lead Auditor and conducted audits, wrote final audit reports, and held final review meetings with the senior management team for top tier pediatric cancer research center.
• Lead change control process for SOPs, lead SOP review committee to ensure compliance with internal procedures and GMP/GTP/FACT/ HIPPA regulations for top tier pediatric cancer research center.