Business Change Lead (PMO)

Role Summary

Location: Zebulon, North Carolina, USA. The purpose of this role is to project manage New Product Introduction (NPI) projects and activities for the Zebulon site to ensure new products are successfully introduced. New products to Zeb include GSK products/chemical entities transferred from within GSK R&D, in-licensing and/or 3rd party contract manufacturing, and Global Supply Chain (GSC) / GSK business transfers to Zeb.

Responsibilities

• Have overall responsibility for the successful project delivery of Zeb site new products, product line extensions, in-licensed products, 3rd party contract manufacturing products and product transfers to the Zeb site (also may have specified involvement in other strategically important site projects, where deemed appropriate).
• Project management of allocated NPI projects through development, clinical trials, registration / stability batches and validation batches, culminating in launch and commercialization.
• Ensure that the delivery of new products, line extensions and new technology is both successful and robust.
• Development of project plans, and monitoring of adherence to plans, to achieve key project milestones, whilst developing appropriate contingency and securing suitable resources.
• Represent Zeb site and GSC (where required) on cross functional project teams led by GSK central / R&D groups or 3rd party organizations.
• Lead on-site multi-disciplinary project teams to deliver projects, which typically consist of representation from multiple functions including quality, production, engineering, logistics, finance, microbiology, analytical and technical teams (team size may be up to 20 personnel dependent on size and scope of project).
• Escalate any potential resource conflicts, capacity issues, supply challenges or technical difficulties to the Site Engineering, key stakeholders and / or Site Leadership Team (SLT) for support and resolution (and agree any off-site communication as appropriate).
• Effectively communicate and/or escalate progress on key batch activities to central functions / off-site teams as agreed.

Qualifications

• Required: Bachelor’s degree in engineering, Pharmaceutical Sciences, Chemistry, Biology, or related field required.
• Required: Knowledge of product portfolios
• Required: Knowledge of technology transfer and Chemical Manufacturing and Controls process.
• Required: Knowledge of GSK commercial operations
• Required: Business and Technical expertise in a regulated industry program delivery
• Required: Experience with regulatory processes and their requirements for global markets and individual dose forms.
• Required: Experience leading on-site cross functional teams.
• Preferred: Master’s and/or PMP (or equivalent) preferred, with substantial NPI/manufacturing transfer experience accepted in lieu of advanced degree.
• Preferred: The ability to plan effectively in order to deliver sustainable business change programs.
• Preferred: Excellent interpersonal skills, including the ability to work across the organization and interact/influence/negotiate effectively at all levels of management and peers.
• Preferred: Ability to work well under pressure with tight timelines.
• Preferred: Excellent consultative, listening, communications and analytical skills.
• Preferred: Must be flexible, adaptable and a strong team player.
• Preferred: Negotiation and conflict resolutions skills and ability to motivate highly skilled and trained individuals.
• Preferred: High energy level, pro-active self-starter.
• Preferred: Excellent written and oral communication skills
• Preferred: Professional Project Management certification preferred.
• Preferred: Black Belt or Green Belt desirable.
• Preferred: Broad Knowledge and experience to understand the links and identification / management of Risks between the Business, Technical, Operational and Support aspects of project delivery.

Additional Requirements

• Work arrangement: This role is hybrid. You will work on-site at US locations as required and have flexibility to work remotely part of the week. Occasional travel between sites may be required.