ROXANNE FANCHER

Lead complex nonconformance & CAPA investigations, performing in depth root cause analysis and ensuring timely, compliant and well documented corrective actions aligned with cGMP and internal standards.

• Oversaw full lifecycle of CAPA process, ensuring timely progression, accurate documentation, and effective verification. Also implemented corrective actions that saw a reduction in verification of effectiveness failure rates from 33% to 0% in the span of 8 months.
• Analyzed complaint trends and data to identify systemic issues, implementing continuous improvement projects to enhance product and process quality.
• Collaborated cross-functionally with manufacturing, engineering and quality teams to resolve complex product quality issues and implement sustainable process improvements. Many of which were adopted across multiple sites internationally.
• Support and participate in internal audits and regulatory inspections, ensuring audit readiness and timely closure of findings in alignment with cGMP and ISO 13485 requirements.

• Played a key role in successful launch of eight new centers across the region, driving quality and compliance readiness, supporting operational implementation, training staff, and ensuring new locations met regulatory and organizational requirements prior to opening.
• Led quality assurance activities in high volume, highly regulated environment, where I maintained a strong audit compliance record, managing and supporting internal and external audits with zero major observations.
• Identified quality system gaps through metrics analysis and implemented process improvements, including revising several SOPs to enhance compliance and operational efficiency.
• Developed comprehensive reports on quality issues and trends, providing actionable recommendations for corrective actions.

• Conducted quality control testing and sample processing with HPLC, LCMS, and UV-VIS spectroscopy to ensure product integrity.
• Supported manufacturing and laboratory operations, ensuring accuracy, compliance and adherence to established protocols.
• Diagnosed sources of error and executed corrective actions, enhancing process reliability.