Hi, I’m
Sarah Champlin
Castroville,TX
Summary
Highly motivated leader with a diverse clinical background and proven results in developing people, products, and continuous quality improvement seeking Upper Management position. Expertise in creating and developing strategic partnerships with clients by providing exceptional customer service. Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.
Overview
20
years of professional experience
1
Certification
Work History
Cellenkos
Manager of QC and Materials Management
01.2021 - Current
Job overview
- Oversight of Investigational Product (IP) distribution for two Phase I clinical trials that are simultaneously enrolling patients.
- Lead on vendor qualification and audits.
- Oversight of reagent qualification to include obtaining FDA approval of research grade material for clinical manufacturing for Phase I clinical trials.
- Oversight of product stability.
- Foster relationships with vendors of frozen cord blood products for starting manufacturing material.
- Oversight of equipment maintenance to include IQ/OQ/PQ and facilities management..
- SOP creation.
- Equipment validation creation and execution.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.
- Streamlined workflows by identifying bottlenecks in existing systems and proactively addressing these challenges through appropriate solutions implementation.
- Ensured compliance with industry regulations and legal requirements by implementing comprehensive policies and training programs for staff members.
- Accomplished multiple tasks within established timeframes.
- Cross-trained existing employees to maximize team agility and performance.
- Maximized performance by monitoring daily activities and mentoring team members.
- Onboarded new employees with training and new hire documentation.
- Established team priorities, maintained schedules and monitored performance.
- Evaluated employee performance and conveyed constructive feedback to improve skills.
- Assisted in organizing and overseeing assignments to drive operational excellence.
BioBridge Global
Assistant Director, Cord Blood Operations
08.2004 - 07.2020
Job overview
- Oversight of operations for GenCure Cord Blood Center.
- Ensured industry standards were followed as defined by the FDA, AATB, AABB, and ISO 9001:2015
- Operational lead/host for regulatory inspections, compliance audits (internal and external), and survey responses for the department as well as addressing audit observations.
- Development and submission of Institutional Review Board (IRB) protocols, consents, and annual reviews while ensuring compliance to protocols.
- Oversight of quality assurance (QA) to include development of SOPs, document control, change controls, supplier qualification, deviation management, investigations, development of corrective and preventive action plans, root cause analysis and training modules.
- Reviewed policies, procedures, and batch records for compliance with client requirements, regulatory requirements, and quality standards.
- Negotiated contracts and quality agreements with clients, vendors and external partners, coordinating with the legal support team.
- Ensured compliance with industry regulations and legal requirements by implementing comprehensive policies and training programs for staff members.
- Assisted in organizing and overseeing assignments to drive operational excellence.
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
- Successfully managed budgets and allocated resources to maximize productivity and profitability.
- Facilitated successful cross-functional collaborations for the completion of key projects, fostering strong working relationships among team members.
- Launched new products and services with thorough market research, leading to increased revenue growth.
- Developed a strong company culture focused on employee engagement, collaboration, and continuous learning opportunities.
- Managed budgets effectively, ensuring optimal financial performance while investing in necessary resources for business growth.
- Established robust risk mitigation strategies to safeguard against potential operational challenges or disruptions.
- Cultivated partnerships with external stakeholders to maximize business opportunities and extend network reach within the industry sector.
- Mentored junior team members for career advancement, fostering a pipeline of future leaders within the organization.
Education
Louisiana State UniversityShreveport, Louisiana
MASTER OF BUSINESS ADMINISTRATION from Project Management
12.2022
Eastern Kentucky UniversityRichmond, Kentucky
BACHELOR OF SCIENCE from Medical Technologist
05.1996
Skills
- Analytical problem solving
- Project Management
- Client Relationship Management
- Sales and Revenue Generation
- New Product Development
- Continuous Improvement
- Leadership and Development of Staff
- Compliance Management
- Operations Management
- Strategic Planning
Websites
Certification
Certified Six Sigma Green Belt
AABB Cellular Therapies Certificate Program
MT (ASCP)
Timeline
Manager of QC and Materials Management
Cellenkos
01.2021 - Current
Assistant Director, Cord Blood Operations
BioBridge Global
08.2004 - 07.2020
Louisiana State University
MASTER OF BUSINESS ADMINISTRATION from Project Management
Eastern Kentucky University
BACHELOR OF SCIENCE from Medical Technologist
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