Jessica Harding
Pikesville,MD
Summary
Strong leader and problem-solver dedicated to streamlining operations to decrease costs and promote organizational efficiency. Uses independent decision-making skills and sound judgment to positively impact company success. Dedicated Industry professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Multi-tasking Manager well-known for creating positive workplace culture and high-performing teams. Demonstrated Product or Service expertise, including competitive offerings, pricing and market positioning. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy.
Overview
15
15
years of professional experience
Work History
Specialist II, QC Laboratory Services
Emergent BioSolutions
11.2019 - 05.2022
- Work with QC, Quality Assurance and third party consultants to revamp Microscopy procedures
- Reduce backlog of particle reporting from 45 days to 15 days by implementation of standard work and visual tools
- Manage day to day operations of particle identification laboratory
- Lead investigations, review and write nonconformance investigation reports
- Write monthly EM and utility reports for department, and report out trends to site QMR for environmental monitoring, OOS and testing
- Review, write and approve protocols, reports, batch records, SOPS and other compliance related documents, as required
- Collaborate with department management, and subcontractors on process improvement of environmental monitoring program
- Manage quality systems task progress and performance to plan (tasks such as: HACCP, CAPA, change controls, compendia review, gap assessments, and operational excellence cross) to ensure compliance requirements, and milestones are identified and met
- Responsible for assisting the department Director in the budget, including planning, cost/resource implications of the proposed work plans and tracking expenditures
- Communicating project status, issues, and successes to department management.
- Enhanced team productivity by streamlining processes and implementing time-saving strategies.
- Developed strong client relationships through consistent communication and attentive service.
- Reduced costs by identifying inefficiencies in operations and implementing cost-saving measures.
- Improved customer satisfaction rates through proactive problem-solving and efficient complaint resolution.
- Organized large-scale events, ensuring seamless execution of logistics, registration, catering, and venue management.
- Managed budgets effectively, consistently staying within financial constraints while maximizing resource allocation for optimal results.
- Mentored junior team members, fostering professional growth through guidance on best practices in the industry.
- Oversaw daily operations of a busy office environment, ensuring tasks were completed efficiently and accurately.
- Followed all company policies and procedures to deliver quality work.
- Collected, arranged, and input information into database system.
- Conducted regular reviews of operations and identified areas for improvement.
- Developed and updated tracking spreadsheets for process monitoring and reporting.
- Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
Senior Project Manager
Emergent BioSolutions
07.2015 - 11.2019
- Manage 10 external clients, with commercial and clinical products
- Utilize procedural requirements for standards and templates for project start-up, budgeting and reporting
- Maintain positive client relationships and cultivate working relationships with clients; sustaining and growing the client base
- Defined Project scope, goals and deliverables that support business goals in collaboration with senior management and stakeholders
- Proactively managed changes in Project scope and prepare change orders promptly for tasks outside the Project scope
- Worked with clients, internal SMEs and QA to onboard client packaging for products distributed to 5 country
- Develop project plans for 6 packaging batch records, printed material specifications and packaging timelines for successful release of product to multiple markets.
Project Manager
Cangene BioPharma
11.2009 - 07.2015
- Coordinate and collaborate with Department Leads to engage cross-functional teams in achieving successful project milestones and fulfilling the clients business objectives
- Lead cross-functional project teams to track billing of project deliverables, budget of project and timelines for product release
- Creating and implementing project plans and tools to oversee project plan execution using Project Management methodologies
- Applying project management best practices in the development, initiation, planning, execution, control and closing of projects
- Define scope, goals, deliverables that support business goals in collaboration with senior management and stakeholders
- Proactively manage changes in Projects scope and prepare changes orders promptly for tasks outside the project scope
- Collect deliverables as required for the change controls and CAPA plans and ensure they meet regulatory requirements
- Manage CDMO client timelines to support milestones of pre-IND to NDA submission
- Ensure that all necessary documentation is completed accurately, timely and in compliance with requirements (drafting user requirements, PQ protocols, and execution of protocols)
- Lead all departments required for successful process development, validation, manufacturing, testing, and releasing of products
- Review, write and approve protocols, reports, batch records, deviations, investigations, and other project related documents, as required
- Create and uphold project plans, schedules, and resource tracking mechanisms for assigned projects
- Collaborate closely with Program Leads to facilitate strategic discussions across functions, particularly concerning project timing, resource allocation, and budgeting
- Provide assistance to the Finance department as necessary in managing overall project costs
- Use SAP to submit quality and financial documents (quality systems documents, sales orders, ship notes, inventory inquiry, and invoice requests).
- Established effective communication among team members for enhanced collaboration and successful project completion.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
- Managed risk assessments and implemented mitigation strategies to minimize potential issues during project execution.
- Coordinated cross-functional teams and resolved conflicts, maintaining a positive work environment throughout the project lifecycle.
- Mentored junior team members in project management best practices to enhance their skills and contribute to better overall performance.
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
- Prepared detailed reports on project status for stakeholders, ensuring transparency and alignment with objectives.
- Developed strong relationships with stakeholders through regular communication updates, fostering trust and confidence in the team''s ability to deliver results.
- Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
- Collaborated closely with senior management to align project objectives with strategic company initiatives, ensuring that efforts contributed to overall business growth.
- Prepared and submitted project invoices for review and approval.
- Scheduled and facilitated meetings between project stakeholders to discuss deliverables, schedules and conflicts.
- Maintained open communication by presenting regular updates on project status to customers.
- Reported regularly to managers on project budget, progress and technical problems.
Senior Manager, Quality Control (QC) Compliance
Emergent BioSolutions
05.2022 - Current
- Manage day to day operations of microscopy laboratory and QC compliance personnel
- Responsible for the internal communications for quality system tasks assigned to quality assurance
- Managed the staffing requirements, work effort and project deliverables for quality control compliance
- Develop KPI goals and reporting for QC compliance
- Proactively identify, assess and manage compliance risks for the QC department
- Manage a cross functional team to manage QC Capex projects, and meet department timelines and budget goals
- Manage investigation system of non-conformances within the QC department.
- Achieved operational excellence by streamlining processes and implementing best practices.
- Improved team performance by providing comprehensive training and fostering a collaborative work environment.
- Increased customer satisfaction with timely project deliveries and seamless communication.
- Reduced costs, optimized resource allocation, and improved efficiency in managing projects.
- Led cross-functional teams to achieve project milestones and deliver high-quality results.
- Developed strategic plans for business growth, resulting in increased revenue and market share.
- Implemented productivity benchmarks across all departments to maximize company revenue.
- Streamlined and monitored quality programs to alleviate overdue compliance activities.
- Leveraged data and analytics to make informed decisions and drive business improvements.
Laboratory Supervisor
University of Maryland Medical Center
10.2008 - 07.2009
- Supervise 10 medical technicians and specialists
- Create and maintained schedule of on-call technologist, for a 24-hour, 7- day a week working lab schedule
- Manage cross functional team meetings with Laboratory and medical stat where reports for transplant team decisions on cross matching communicating test results, manage patient files and schedule urgent testing in the lab, support of patient care planning in transplant department
- Manage laboratory management, Capex projects and inventory and procurement for laboratory
- Supervise performance of others and making hiring decisions for staffing the lab
- Write and reviews standard operating procedures.
Education
MBA -
Keller Business School
05.2014
Bachelor of Science Biology -
Washington College
05.1998
Skills
- SOP writing and protocol development
- Customer service
- Supervision and personnel management
- Proficient with SAP, Excel, Adobe PageMaker, Microsoft Office, Microsoft Project, Microsoft Project Server, and Microsoft Teams, Power Point, SharePoint, iRenaissance, Veeva, eDocs, Teams, Track Wise and SmartSheet
- White and Yellow belt certified at Emergent BioSolutions
- Data Analytics
- Budget Oversight
- Cross-Functional Collaboration
- Data-Driven Decision-Making
- Troubleshooting and Problem Resolution
- Product Development
- Process Improvement
- Change Management
- Quality Assurance
- Customer Relationship Management
- Cross-functional Team Coordination
- Project Management
- Risk Management
- Performance Management
- Employee Coaching and Mentoring
- MS Office
- Shift Scheduling
- Preventive Maintenance
- Performance Reviewing
- Decision-Making
- Task Delegation
- Teamwork and Collaboration
- Professional and Courteous
- Hiring and Training
- Goal Setting
- Computer Skills
- SOP writing and protocol development
- Regulatory Knowledge
- Special Projects
- Lean Methods
- Project Requirements
- Write Reports
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
If only we’d stop trying to be happy we’d have a pretty good time.
Edith Wharton
Timeline
Senior Manager, Quality Control (QC) Compliance
Emergent BioSolutions
05.2022 - Current
Specialist II, QC Laboratory Services
Emergent BioSolutions
11.2019 - 05.2022
Senior Project Manager
Emergent BioSolutions
07.2015 - 11.2019
Project Manager
Cangene BioPharma
11.2009 - 07.2015
Laboratory Supervisor
University of Maryland Medical Center
10.2008 - 07.2009
MBA -
Keller Business School
Bachelor of Science Biology -
Washington College
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