End to End Project Lead
- Collaborate with senior management and stakeholders to define business requirement including scope, goals and deliverables to support business objectives.
- Align projects with strategic goals (market, strategy, profitability) and provide justification from market, strategic, and economic perspectives.
- Validate the business case and CAR can be delivered from a cross-functional perspective (including CAPEX, operations, process, procurement, QA, HR, etc).
- Build and lead a diverse, high-performing team structure that supports delivery goals, offering mentorship, development opportunities, and performance feedback.
- Translate user requirements into actionable design inputs and be responsible for delivery of outcomes that meet cost, timeline, and functionality targets.
- Partner with sponsor to develop the project plan and execution strategy and to set-up the contractual framework.
- Partner with Production planning to integrate downtime and production capabilities into the Master Production Schedule.
- Ensure optimal flow of information within project organization and at collaborate with Global Engineering and the project steering committee and mediating in case of problems.
- Manage scope changes in alignment with Global and Local Engineering Project Leaders.
- Drive Operational Readiness, develop an integrated plan, track progress and implement mitigation actions as appropriate in close collaboration with Quality ensure cGMP Compliance for successful PPQ and timely Regulatory approval.
- Bachelor’s degree in Life Science, Engineering or Business Management. Master’s degree preferred.
- Demonstrated success in operational management, PMP Project Manager Certification, 6S and Lean Manufacturing, Lean Six Sigma green belt or black belt is preferred.
- 10+ years of experience in Manufacturing /operations role within the pharmaceutical, biopharmaceutical, or a similar regulated industry.
- Data driven decision maker and problem solver, with strong problem-solving skills.
- Understanding of operational excellence, including continuous improvement methodologies (e.g. Lean, Six Sigma, etc.)
- Strong understanding of and proven experience with cGMP requirements for biologics manufacturing.
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