Assistant Manager of Quality - CSL PLASMA - Tallahassee, FL
(2024-12)
Provide quality leadership and oversight for plasma collection operations, ensuring compliance with applicable regulatory requirements, company standards, cGMP/GDP principles, quality systems, and site procedures.
- Lead day-to-day quality activities and provide strategic quality guidance to site leadership and cross-functional teams.
- Partner with Operations, Medical Affairs, Training, and other functional leaders to strengthen quality performance and ensure consistent execution of quality requirements.
- Promote a culture of quality ownership, accountability, continuous improvement, and proactive risk management across the site.
- Coach and develop Quality personnel while establishing clear expectations, performance standards, and opportunities for professional growth.
- Support leadership decision-making through analysis of quality trends, risks, deviations, CAPAs, and key performance indicators.
- Provide oversight of site quality systems, including deviations, CAPAs, investigations, document management, training compliance, quality reviews, and quality trending.
- Ensure quality events are appropriately documented, investigated, risk-assessed, and closed within established timelines.
- Conduct and/or support root cause analysis using structured methodologies such as 5-Why and Fishbone analysis.
- Evaluate donor, product, process, and compliance risks associated with quality events and determine appropriate containment and corrective actions.
- Monitor quality-system performance and identify recurring trends requiring systemic corrective or preventive action.
- Lead and support site preparation for internal, corporate, regulatory, and quality-system audits.
- Assess site compliance against applicable procedures and regulatory expectations and coordinate remediation of identified gaps.
- Maintain a state of continuous audit readiness through proactive review of documentation, training, equipment, processes, and quality records.
- Partner with site leadership to address quality findings and establish sustainable corrective actions.
- Analyze KRI, deviation, CAPA, error, compliance, training, and quality-trending data to identify performance gaps and emerging risks.
- Develop action plans to address adverse trends and improve site quality performance.
- Use data-driven analysis to identify opportunities for error reduction, process improvement, compliance improvement, and cost-of-poor-quality reduction.
- Support implementation of quality initiatives designed to improve process reliability and reduce recurring errors.
- Monitor effectiveness of corrective actions and verify sustained improvement through follow-up trending and effectiveness checks.
- Develop and deliver quality-focused training and coaching to site personnel.
- Partner with leadership to improve on-time training completion and employee understanding of SOP and quality expectations.
- Reinforce quality ownership through employee recognition, coaching, feedback, and engagement.
- Support development of Quality staff through targeted development plans and ongoing performance feedback.
Innova Quality Lead - CSL Plasma - Tallahassee, FL
(2023-07 - 2024-12)
Provided quality leadership for Innova-related quality initiatives while supporting site quality operations, compliance, training, and continuous improvement.
- Led quality initiatives supporting operational compliance, process consistency, and quality-system effectiveness.
- Reviewed quality data and trends to identify recurring issues and opportunities for preventive action.
- Supported investigations, deviations, CAPAs, root cause analysis, and effectiveness checks.
- Collaborated with Operations and Quality leadership to implement corrective and preventive actions.
- Supported audit readiness and compliance activities by reviewing records, processes, and quality documentation.
- Provided coaching and technical guidance to employees regarding quality expectations, SOP compliance, and process execution.
- Supported implementation and sustainability of quality improvement initiatives.
- Used quality metrics and trending information to identify opportunities to reduce errors and improve process performance.
- Served as a quality resource and liaison between operational teams and Quality leadership.
Quality Training Specialist | Quality Specialist - CSL PLASMA - Houston, TX
(2023-07)
- Delivered and supported quality and compliance training for employees across multiple operational functions.
- Supported implementation and maintenance of training programs aligned with SOPs, regulatory expectations, and quality-system requirements.
- Monitored training compliance and identified overdue or recurring training gaps.
- Provided coaching and reinforcement of procedural requirements to improve employee performance and compliance.
- Supported quality investigations, documentation reviews, deviations, CAPAs, and quality trending.
- Participated in audit-readiness activities and quality-system reviews.
- Assisted with identifying process weaknesses and implementing sustainable corrective actions.
- Promoted a strong quality culture through employee education, coaching, and continuous feedback.
