Danielle Keene Email & Phone Number

Raleigh, Nc, Us

Raleigh, Nc, Us

Tarrytown, New York, Us

• Assist with the oversight of GDQA systems management. • Assist with the oversight of GDQA personnel including resourcing and assignments, and training and development.• Represent GDQA on teams, compliance projects and initiatives both within and across functional areas of Global Development, or other departments, as applicable.• Training/orientation of new GDQA staff.• Identify opportunities for continuous improvement within GDQA and the organization.

Tarrytown, New York, Us

• Assist with the oversight of systems management including: • Manage external CAPA process • Quality Event Management System (QEMS) Support for GDQA function • Support Trend Analysis & Metrics Review (identify and escalate positive and negative trends) • Assist with the oversight of GDQA personnel including: • Resourcing and assignments • Training and development• Assist with the oversight of GDQA procedures including: • Identifying & managing SOP/WI/BPT/Template improvements • Monitoring and managing Procedural Deviations • Internal resource to answer GDQ procedural questions • Represent GDQA on teams, compliance projects and initiatives both within and across functional areas of Global Development, or other departments, as applicable. • Support clinical studies as a strategy representative to develop and execute risk-based audit programs for assigned studies (GCP). • Assist with training/orientation of new GDQA staff • Identify opportunities for continuous improvement within GDQA and the organization

San Diego, Ca, Us

• Developed and implemented an audit tracking tool that included essential clinical quality metrics.• Performed a gap analysis on current and historical audit documentation and implemented mitigations. • Developed a clinical investigator FDA inspection readiness training program.• Developed a process for the clinical quality training program.• Co-authored the internal observation area and regulation matrix. • Provided clinical quality oversight for assigned protocols. • Reviewed clinical trial protocols.• Contributed to the development and review of SOPs and other controlled documents (forms, templates, work instructions).

Tarrytown, New York, Us

• Manages the QMOD Business Support mailbox and provides customer support for QMOD. Works on QMOD configuration changes by helping to assess impact, and reviewing changes for business alignment to SOPs.• Supports Business Administration for QMOD, including minor changes in picklist values, and the communication of changes to stakeholders.• Assist in the management of files and associated data/metrics supporting the Process Deviation, CAPA, and other Quality Events overseen by the GCP Quality Improvement• Assist where needed with scheduling alert meetings for QMOD and Process Deviations• Provides support in the investigation of Quality Events as needed by tracking timelines to assure that projects are completed on time• Supports closure of CAPA action items, when needed• Disseminates essential information and status updates to management on assigned projects

• Project managed FDA commitment initiatives including administrative tasks, QMS integration, and audit trail review. • Supported the Audit Trail Review Assessment project and CAPA progress by coordinating scope with leadership, identifying stakeholders, managing the completion of assessments, tracking task completion, and reporting in CAPA evidence and project summary report. • Supported internal quality integration audit including backroom support, coordinating responsible teams, preparing storyboards, and archival in the QMS system.• Closed Quality Management System integration training CAPA by coordinating and collecting evidence for 120 training records. • Closed three (3) QMS Integration CAPAs by co-managing all phases including the assessment of 120 QMS documents and revision/creation of 275 QMS documents. Provided support to various organizational team and leadership via guidance materials, facilitating cross functional collaborations, and tracking and metric reporting.• Managed CAPe Team maintenance, including; maintaining team tools and documentation, reporting metrics, coordinating team collaborations, and long term transition activities.• Collaborated on the 2020 CAPe Team budget build, including; researching costs through discussion with internal personnel, trending of previous cost data, and designing a cost model.

New York, Ny, Us

• Supported continuous improvements in the CAPA processes and procedures through development of trending and management tools, leading initiatives to complete backlogged and overdue CAPAs prior to implementation of new electronic QMS system, and providing training to stakeholders. • Facilitated the completion of CAPAs within specified timelines, including conducting cross functional team meetings, reviewing identified issue, and collaborating to develop corrective and preventive actions.• Supported regulatory compliance by performing internal GCP audits relating to the TG Trial Master File(TMF).• Led a certified scanning of TMF documentation for a legacy project, including developing the plan, forms, training materials and coordinating the project execution.

New York, Ny, Us

• Managed projects related to FDA submission and inspection readiness including developing the supplier quality program. • Supported the development of the corporate wide supplier qualification program resulting in the qualification of 50% of the suppliers in a 7 month time period through internal process assessment, developing process materials, training personnel, establishing routine meetings, point of contact for CROs, and maintaining all tools and documentation. • Supported the implementation of the supplier audit plan for 2019 with the TG Quality leadership team by managing 15 vendor audits through on-boarding consulting firms and auditors, scheduling, managing communication, and coordinating audit report follow up and distribution. • Supported process improvement project to enable the consolidation of clinical study AE data into a central location through developing and implementing a QC plan, coordinating the resulting remediation/mitigation actions, and participated in stakeholder meetings to develop and review transfer specifications, configuration specifications and associated management plans.• Supported clinical study risk assessment process by collaborating with cross functional team members and consolidating relevant inputs into risks and actions documented in a mitigation plan.• Collaborated in inspection readiness projects including gap analyses, issue resolution, issue mitigations and planning.• Supported the QMS through in implementation of applicable SOPs, quality management review and gap assessments of various QMS processes and Quality Event and CAPA process support.• Participated in computer validation activities such as validation deliverable creation, testing, and training material development for GxP Systems.

• Coded and entered invoices each day into the in-house accounting program in Excel.• Provided invoice distribution and issue resolution to clients.• Directed all administrative tasks for the office.• Successfully implemented new technologies and process automation to encourage continuous improvement.

• Interviewed clients to determine reason for visit and document concerns.• Educated clients on animal care, nutrition, medical conditions and disease management.• Maintained accurate pharmacy records and controlled drug, anesthesia, fecal, and heartworm test logs.• Administered prescribed injectable controlled substances, tranquilizers, sedatives, and injectable or inhalant anesthetics.• Assisted veterinarian during surgical procedures by creating and maintaining unobstructed surgical fields, monitoring anesthesia and passing instruments.

Lexington, Ma, Us

• Assisted in the evaluation of new techniques and procedures for the purpose of product development in a GLP environment.• Maintained accurate research documentation including test product delivery, observations, and protocol deviations.• Assisted client in test subject surgical preparation via pre-operative health status, administering anesthesia ,IV placement and special requirements.• Maintained accurate health records, pharmacy records, and controlled drug and anesthesia logs.• Administered medications, vaccines, and treatments as instructed by veterinarian.