Project Manager (GMP Manufacturing Operational Excellence)
The Project Manager will manage the successful lifecycle of strategic or operational projects and programs in accordance with timelines, budgets and quality standards. Will have responsibility for the oversight and execution of GMP manufacturing projects within the Operational Excellence organization.
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.
• Bachelor's degree.
• 3 years' experience working with and managing projects in the biotechnology or pharmaceutical industry to include processes of scope development, cost estimating, scheduling, change control, quality control, risk management, procurement, contracting and reporting.
• Thorough knowledge of GMP manufacturing, and understanding of validation of pharmaceutical facilities, equipment and processes. Knowledge of cGMP regulatory compliance standards and regulatory filings.
• Proficient in MS Project, Excel, Word, PowerPoint.
• Demonstrated ability to interact in multidisciplinary environment including engineering, facility operations, validation, production and QC\QA. Ability to work across functional disciplines.
• Demonstrated ability to provide leadership to generate options, resolve problems, prioritize solutions, select optimal solutions and implement decisions.
• Ability to manage multiple projects and priorities simultaneously in order to achieve deliverables and adhere to timelines and budgets.
• Post graduate degree, MBA or degree in a related discipline (i.e. Business, Science, Engineering, etc.)
• PMP Certification or other closely related Project Management certification.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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