Monique Sprueill, PMP, CQA, CSSGB, CMQ-OE

Design and implement end-to-end Quality Strategy for GCP Process Areas.

• Engage with stakeholder and leverage quality management system (QMS) data to proactively assess risks associated with Clinical Trials execution.
• Generate quality strategies and narratives that summarize risks, action plans and CAPA effectiveness.
• Partner with Therapeutic Area Quality Leads and Global Process Owners to identify opportunities for process improvement within functional areas.
• Develop audit strategies to ensure potential quality compliance risks are identified and assist functional areas in inspection readiness.
• Benchmark best practices to support successful outcomes during Health Authority (HA) engagement.
• Represent Process Quality on cross-functional teams to manage quality issues.

Led regional quality team in Clinical and Commercial Supply delivery of $20B+ Large Molecule portfolio.

• Defined quality strategy and strategic account plan for external Biologics Drug Product and Drug Substance manufacturing sites.
• Implemented a fit-for-purpose model to facilitate the appropriate level of quality assurance oversight for Drug Product and Drug Substance external manufacturing sites across North America.
• Optimized department resource model to support business objectives and mitigate risks, resulting in no major supply interruptions due to Quality related issues during the height of the Covid-19 pandemic.
• Led external supplier qualification audits to confirm that biologics manufacturing and packaging site capabilities, procedures and practices complied with global regulations and industry standards.
• Effectively managed budgets to ensure optimal use of resources while maintaining financial stability.
• Enhanced team collaboration through regular communication, goal setting, and performance evaluations.
• Approves Annual Product Reviews (APR) and Product Quality Reviews (PQR).

Led cross-functional teams to cohesively drive organizational success and deliver high-quality results.

• Championed process improvement initiatives that led to increased capabilities and efficiency without compromising on quality standards.
• Balanced competing priorities across Quality & Compliance functions efficiently while maintaining focus on critical tasks requiring immediate. attention.
• Collaborated closely with stakeholders to define and manage strategy execution activities in support of Q&C strategic focus areas.
• Monitored and reported the progress of key programs for Quality System Management Reviews.
• Promoted a culture of continuous learning through regular workshops.

Partnered with Life Science industry leaders to strategically manage risks and implement value-added, quality-compliant solutions.

• Enhanced client satisfaction by maintaining open lines of communication and ensuring high-quality service delivery.
• Monitored and analyzed client organization's performance to identify opportunities for improvement and propose recommendations.
• Evaluated employee performance and conveyed constructive feedback to improve skills.
• Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.

Oversaw quality assurance at contract manufacturing, research, packaging and laboratory organizations in support of technology transfers, product launch and routine operations for controlled substances, sterile and non-sterile pharmaceuticals and combination (pharma/medical device) products.

• Collaborated with cross-functional teams to resolve multiple start-up issues with aseptic filling and packaging operations, driving on-time readiness for $80M complex generic product launch.
• Managed annual $700K budget for contract laboratory analyses and stability testing.
• Assessed key performance indicators (KPIs) and drove continuous improvement initiatives.
• Reduced change control and CAPA approval time by 75% by optimizing workflow and communication with contract service providers.
• Reviewed and authored Annual Product Reviews (APR)/ Product Quality Reviews (PQR).

Performed process validation and equipment qualification in support of cGMP Operations, process improvements, and system upgrades at a Solid Dose Pharmaceutical facility.

• Collaborated with Site Engineering, Quality Assurance, and Operations to ensure that new and existing equipment were qualified and ready for release to production per project schedule.
• Reviewed and evaluated technical documentation for completeness and accuracy.
• Authored and executed quality plans, validation protocols and summary reports.

Engineering Team Lead for capital (CAPEX) and continuous improvement projects up to $170M in support of vaccine production operations.

• Led Commissioning and Qualification efforts to increase capacity and production capabilities in aseptic manufacturing areas.
• Oversaw Vaccine process equipment design, installation, qualification, budget, resource management and vendor relationships for U.S. Health and Human Services (HHS) facility retrofit project.
• Managed budget and resources and prioritized process support activities.
• Utilized Risk Management tools (FMEA, Fish-bone Diagrams, and Risk Assessments) to evaluate equipment/process capabilities, troubleshoot issues and mitigate risks.

Managed multiple validation projects simultaneously while adhering to strict deadlines and budget constraints.

• Reduced operational risks associated with validated systems through periodic review assessments and targeted additional testing when necessary.
• Conducted root cause analysis on deviations during validation activities, enabling timely resolution of technical issues.
• Collaborated with third party regulatory oversight personnel and approved quality documentation in support of $15M Consent Decree remediation.
• Led Commissioning, Qualification and Validation (CQV) execution in Central Utilities Building and Laboratories for a $750M Biologics facility construction and start-up project.
• Performed IQ, OQ, PQ, CIP, and Packaging Validation (PkV) studies in support of technology transfers, process improvement and start-up activities.