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Warehouse Project Manager CAR-T
Job Details
Location: Gent
Published: 1 day ago
Application Deadline: October 22, 2023
Contract: 40 hours per week
Reference: CXRSP-110276
The Warehouse Project Manager will be responsible for process improvements and continuous improvement of the cGMP Warehouse Operations within a state-of-the-art manufacturing facility for cell therapy with multiple products that will be used for the production of autologous and allogeneic cell therapy products. This person will collaborate with Technical Operations and other functions to support the production and distribution of cell therapy products through safe and compliant operations according to cGMP requirements.
Main Responsibilities
1. Recruit, lead, and coach a team of Warehouse Project Specialists to support the continuous improvement objectives and initiatives of warehouse and logistics activities, and define and manage projects to achieve and realize them.
2. Support and collaborate with the company's training department, map the capabilities within the team, assist in setting up training programs and development pathways, conduct regular evaluations and review sessions to ensure process compliance of activities.
3. Define project management KPIs in line with Lean Six Sigma, DMAIC, and other relevant project management tools. Present and report project results to colleagues and senior management. Plan the project timeline based on resource availability and warehouse team capabilities, and act as a point of contact for the company's PMO organization, supporting business programs from the perspective of the warehouse team (material flow, people flow, continuous improvement, etc.).
4. Support the creation, monitoring, planning, and implementation of projects related to the business requirements of Warehouse & Operations. Align with all relevant stakeholders to meet GXP requirements.
5. Act as the leading person from warehouse functions in leading functional quality investigation-related activities and responsible for timely closure of deviations, quality investigations, and CAPAs related to operational activities. Ensure good CAPA effectiveness checks to maintain quality and compliance of daily activities.
6. Take responsibility for best practices in warehouse and logistics according to Legend Biotech policies and GXP requirements. Ensure that operational activities comply with GXP, quality, training, EHS, and security requirements. Develop solutions to improve quality, efficiency, capacity, safety, and security.
7. Participate in EHS improvement and culture change within teams. Engage in risk assessments within the warehouse. Ensure that safety observations identified during operational activities are addressed and that the implementation of improvements is supported. Sponsor safety within the organization.
8. Participate in and conduct internal audits. Responsible for documentation improvements and warehouse and logistics-related GMP procedures. Lead the evaluation and improvement and/or update SOP and WI together with internal stakeholders to meet legal, safety, and quality standards.
9. Support audit readiness by conducting associated gap assessments and timely executing/supporting associated actions. Ensure a mindset of high safety standards and cGMP compliance, ensuring the reliability of warehouse activities and readiness for audits or inspections at all times.
10. Train and evaluate the functional organization in the compliant execution of SOP and WI concerning the business requirements of Warehouse & Operations.
Your Offer
1. PhD or master's degree in science, supply chain, logistics, or a related field or equivalent experience required.
2. 8+ years of experience in supply chain or equivalent with a background and management for continuous improvement.
3. Experience: 5 to 8 years of project/program management experience, preferably in the pharmaceutical industry and in the clinical supply chain.
4. Experience with process engineering, 5S, and continuous improvement.
5. Experience and strong affinity with QI & deviation management.
6. Strong knowledge of GMP and GDP.
7. Initial experience with people management and coaching.
8. Skills and Abilities: Ability to work independently and successfully, prioritize and manage multiple tasks simultaneously, integrate cross-functional issues, and effectively balance competing priorities. Must be able to manage changing priorities to meet critical deadlines in a fast-paced and dynamic, growing environment.
9. Strong in effectively communicating and collaborating with broad stakeholders across various scientific/technical/business disciplines.
10. Strong analytical, problem-solving, and critical thinking skills and the ability to lead as a change agent to foster flexibility, creativity, and accountability.
11. Very strong influencing skills with the ability to communicate effectively and convey messages at all levels of the organization and across functions.
12. Excellent teamwork and interpersonal skills with the ability to influence and build strong working relationships at all levels within the organization.
13. Advanced knowledge of warehouse operations, including best industrial practices, application of principles, concepts, practices, standards, validation, and qualification within a cGMP manufacturing environment.
14. Advanced skill in using ERP systems, warehouse management systems, and analytics.
15. Ability to promote a mindset of continuous improvement, problem-solving, and prevention.
16. Languages: Fluent in English, preferably fluent in Dutch.
Our Offer
Permanent contract with the company/client.
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