Lori Drum Email & Phone Number

Chapel Hill, Nc, Us

• Align the work of the Oncology Quality department with other related Pfizer Quality organizations• Devise overall strategy• Orchestrate identification, prioritization, and advancement of initiatives; monitor progress and communicate to internal teams and external stakeholders.• Establish and monitor department goals and priorities in alignment with Oncology Division needs, and in coordination with other Quality organizations in Pfizer Research & Development and Regulatory QA• Manage L-RDQ integration framework and support execution• Support advancement of a strong culture of Quality• Execute periodic planning processes, including budget and resourcing• Support key functional governance committees

New Hill, North Carolina, United States

• Support and manage R&D Quality programs from an operational and strategic perspective.• Manage and set leadership agendas.• Coordinate and optimize critical activities, quarterly/annual planning processes, and inspection management activities.• Orchestrate identification, prioritization, and advancement of initiatives; monitor progress and communicate to internal teams and external stakeholders.• Advise, report on, and ensure execution of initiatives, priorities, and corporate and departmental goals to ensure alignment with desired outcomes.• Provide continuous improvement mentorship to teams, openly sharing guidance and technical expertise.• Lead efforts to develop a strong culture of Quality across the company, including administering and analyzing assessments.• Create and manage successful departmental program/project management framework and tool.

Durham, Nc

• Oversight of and facilitation over all LCS systems and technology governance and roadmaps.• Gap coverage and implementation of technology project intake and risk managementframeworks.• Management and maintenance of LCS System inventory including periodic reviewresponsibilities.• Tracking and reporting budget spend and ROI for all technology investments as well asconducting yearly budget planning.• Deliver, within the constraints of scope, quality, time and cost, complete Systems Compliance OfficeCAPAs

Morrisville, Nc

Managed projects within the Identity & Access Management (IAM) team. Primary focus was regulated solution development and maintenance, but other projects included infrastructure upgrades and large-scale storage migrations. Successfully overcame challenges resulting from the use of over-extended, non-dedicated resources who were geographically dispersed and often unfamiliar with the need for compliance with prescribed procedures.

* Managed the development of new products related to global network data management. Products include traditional data networks, as well as IP Telephony.* Audited documentation generated by product and project teams.* Lead internal ISO Audit response team.* Activities performed included the creation and/or tracking of training and certification requirements and fulfillment, business and functional requirements, technical specifications and operational process documentation.* Developed SOPs as needed.* Served as primary Operations project POC for various other organizations within the company, such as Marketing, Product Development, and IT.

* Managed system implementation projects within IT department* Wrote and executed business and functional system requirements, software test plans, validation plans, and test procedures for multiple Off-the-shelf and in-house systems.* Planned and conducted audits of regulatory-compliant software development teams; assisted in mentoring IT staff in preparing audit responses to internal and external audits.* Drafted SOPs and Work Instructions (drafted major portions of the Software Development Life Cycle process; created internal audit process infrastructure); assisted in review of departmental SOPs and Work Instructions.* Assisted IT staff and department personnel in the development and enforcement of software development standards. Provided regulatory leadership to staff regarding quality assurance, FDA expectations and Part 11 compliance.* Trained staff on specific applications and processes.

Raleigh, Nc

Served as Board Member of non-profit organization for two 3-year terms. Served as Competition Co-Chair or Chair for 3 years. Represented organization in voting capacity at national conference.

• Created, executed and documented test plans and test cases for web-based publishing system. Conducted testing for all aspects of the release cycle: installation, configuration, and functional use by customers.* Produced bug reports in Remedy tracking database and interfaced with Engineering Department and Product Development Department.• Maintained test environments.

• Performed software quality activities for entire Software Development Life Cycle – requirements; specifications; test plans, infrastructure and test cases; oversaw software configuration management activities• Managed system migration and data conversion projects.• Created new MIS Regulatory Affairs team. Conducted internal product / process audits of development projects.• Responded to MIS audits by customers and regulatory bodies.

Msls, Library And Information Science

Activities and Societies: Beta Phi Mu honor societyDean's Award for Best Master's Paper

Ba, Political Science

Activities and Societies: Nu Sigma sorority, Political Awareness ClubIntern in the Office of the Chancellor; Political Science department.