Project Manager

GSK, Plc.•Marietta, PA

30d•Hybrid

About The Position

You will lead projects that improve how we work and how we serve customers. You will plan, deliver and close projects on time, on budget and to agreed quality. You will work with teams across functions and with external partners. We value people who are organized, clear communicators, and who solve problems with practical, simple solutions. This role offers strong growth, visible impact and the chance to contribute to our mission of uniting science, technology and talent to get ahead of disease together. The Project Manager will be responsible for the complete lifecycle management of projects that will consist of: Define and determine project scope (In-and out-of-scope), charter, areas of responsibilities, and identify stakeholders in collaboration with GSK Marietta and/or global resources. Demonstrated familiarity and compliance with cGMP's, EHS procedures and regulations, facility regulatory guidelines, and standard operating procedures. Decide project resource requirements and resourcing strategy for project team as well as recruit team. Influence key stakeholders for embedded local resources. Establish team roles and responsibilities and time commitments for all team members. Manage project finances, contracts and vendors in accordance with budget and ensure adherence to government reporting requirements, if applicable. Develop detailed project schedules, including but not limited to activities such as; URS development, RFPs, vendor selection and management, equipment delivery and installation, raw material provisioning, master data changes, QC test method transfer, IQ/OQ/PQs, validation protocols/reports/VMP, Automation modifications, LSOP/batch record revisions and approvals, Change Control, engineering runs, hand-over/training local operational team, and support for regulatory filing/submission. Execute project according to plan and maintain critical path. Monitor and communicate progress and ensure project outcomes meet project objectives. Proactively identify project risk areas or production impact and recommend appropriate mitigation or contingencies. Deliver final report at project completion including 1) measurement of success of the project and deliverables defined in the project charter addressing timelines, scope and specifications 2) customer hand-over activities and recommendations for sustainability, 3) Project team AAR, and 4) lessons learned. Manage additional local projects as appropriate, and other duties as assigned. Manage and present project stage-gate reviews across project lifecycle, ensuring readiness criteria are met and decisions are clearly documented. Prepare, consolidate and deliver monthly project performance reporting to the PMO and governance forums, highlighting status, risks, issues, dependencies and recommended actions.

Requirements

Bachelor's degree OR Project Management certifications and 3+ years' experience in project management in a regulated industry.
3+ years project management experience in a regulated or complex industry.
Proven experience managing cross-functional teams and stakeholder engagement.
Experience managing vendors, contracts and project budgets.
Knowledge of cGMP regulatory compliance standards and regulatory filings.
Proficient in MS Project, Excel, Word, PowerPoint.

Nice To Haves

Post graduate degree or related discipline and experience
Project Management Professional (PMP) or similar certification.
Experience in biotechnology, pharmaceutical, manufacturing, or highly regulated environments.
Familiarity with Good Manufacturing Practice (GMP) principles and facility validation.
Experience delivering multi-year or multi-million-dollar projects.
Strong data analysis skills and ability to translate insight into action.
Experience with change management and operational readiness activities.
Ability to manage multiple projects and priorities simultaneously in order to achieve deliverables and adhere to timelines and budgets.
Ability to achieve effective execution of complex projects and programs
Driven by delivering "On time, on cost, and on specification" through a team.
Ability to communicate both verbally and in writing with all levels of the organization. The ability to communicate ideas and concepts in a clear, compelling way.
Personally agile in a political situation, will not compromise objectivity, independence or project governance.
Ability to make oral group presentations and facilitate team discussions to include persuading others, providing information, explaining concepts, and delivering business cases
Creates culture of openness and objectivity, so issues and risks are well managed.
Executive capability and leadership to manage people and field projects teams.
Must be able to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
Able to interact in multidisciplinary environment including engineering, facility operations, validation, production and QC\QA. Ability to work across functional disciplines.
Ability to work in a highly complex matrix and multi-cultural environment.
Ability to effectively influence across functions at all organizational levels
Stay current on developments in the field and GSK Vaccines Standards.

Responsibilities

Create clear project charters, schedules and success criteria.
Coordinate procurement, equipment installations, testing and operational readiness activities when required.
Ensure projects meet quality standards and applicable regulatory or safety requirements.
Use data and customer insight to inform project decisions and improvements.
Support change adoption through stakeholder engagement and training plans.
Maintain accurate documentation and final project reports.