We are looking for Program Manager for our client in Alameda, CA
Job Title: Program Manager
Job Location: Alameda, CA
Job Type: Contract – 12 Months / Contract to Hire / Direct Hire
- Design Control adherence
- Develop & maintain program schedule & budget
- Develop & maintain D&D plan
- Drive Human Factors validation
- Report status to Project Lead and Sr. Management
- The Sr. Engineering Manager performs dual responsibilities of Technical and Project Manager. As a Technical Manager, provides an exceptional level of technical know-how and expertise within a specialty field(s) within the Engineering organization. As a Project Manager, lead the preparation and execution of project plans for multi-million dollar New Product Implementation projects, Capital Improvement projects, and assists with the development and continuous improvement of standard work for project management.
- The Sr. Manager manages cross-functional team resources throughout the project life cycle and is accountable for meeting the agreed upon project scot, schedule, budget and quality. Collaborate with internal resource managers and external partners to properly staff their project and manage project risk to ultimately provide an end result that performs at the expected quality level. In addition, the Sr. Manager will support the development and improvement of project management systems, including the phase/gate process for new product innovation and development, using industry best practices (e.g., Lean Product Development). The PM will have an understanding of Manufacturing Controls (CMC) requirements (e.g., cGMP, GCP, USP), and skills and experience in the use of world class project management principles (e.g., PMI PMBOK).
Responsibilities / Essential Duties:
- Partner with global cross-functional team members, equipment design vendors, architectural and engineering firms, and otherinternal and external stakeholders as necessary to prepare business cases and justify capital for proposed new projects.
- Lead or provide tactical guidance for the planning and execution of new product projects from the Conceptual phase through Closure. This includes responsibilities for facilities, equipment, supply chain, and other outside services, staffing, operating procedures, policies and standards.
- Manage project team resources to achieve the agreed upon goals of the project, including the project schedule and budget, as well as the quality (e.g., scope and performance).
- Collaborate with the Project Sponsors, existing Business Units, Marketing, Finance, Operations, Quality, Facilities, Maintenance, Regulatory Affairs, and other stakeholders to ensure the seamless phase-in of new products.
- Ensure the effective use of human, physical and financial resources in order to achieve company objectives.
- Evaluate team member performance.
- Set short term and long term goals for continuous improvements (e.g., using Value Stream Mapping) to reduce costs, eliminate waste and improve processes to achieve product quality, customer satisfaction, product cost goals, and other key performance indicators.
- Monitor and confirm organizational adherence to policies, procedures, regulations and standard work.
- Drive and support implementation of major cost savings and continuous improvement projects (e.g. Kaizen events).
- Communicate effectively to all levels of the organization using all forms of communication.
- Drives effective and timely problem solving through the use of team resources and Lean/Quality tools (e.g., DMAIC).
- Responsible for developing, monitoring and achieving any assigned budgetary goals.
- Creates and delivers presentations to all levels of the organization regarding project timing, cost, risks and quality (scope and performance).
- Conducts periodic review with the project team and with management to ensure that phase/gate transition criteria are met in the most efficient manner.
- Cultivates a positive team spirit and a healthy team dynamic. Ensures that the team develops and maintains a common mission and vision of success throughout the project life cycle.
- Draft required project and validation documentation including equipment specifications, operating procedures and protocols (FAT, SAT, IQ, OQ).
- Responsible for performing/supporting quality investigations in a timely and thorough manner per applicable investigation procedures.
- Responsible to review and approve quality investigations to ensure documentation is complete, accurate and timely.
Mandatory Technical / Soft Skills:
- Demonstrated Project Management knowledge of tools, techniques, culture, software applications, such as Microsoft Project.
- Quality Systems, GMP, FDA
- Product development and sustaining engineering knowledge
- Ability to communicate (face to face, team meetings, provide presentations) with every level of the company, as well as with customers and suppliers.
- Good team building skills and ability to lead cross functional / international teams
- Demonstrated success in leading project teams and managing projects from initiation through completion