Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Sr. Device Development Project Manager: EXCLUSIVE REQ
1 DNA Way South San Francisco, CA 94080 US
Posted: 10/27/2023
2023-10-27
2023-12-26
Employment Type:
Contract
Job Category: Project Management
Job Number: 587913
Is job remote?: No
Country: United States
Job Description
Description:
The Device Development Project Manager (PM) will support 2 to 3 projects depending on the stage and complexity level of the program. Project assignments will include pipeline, product care, technology and/or continuous improvement initiatives. In this role the PM will work with limited direction and will effectively prioritize and manage their workload to meet Team goals. The PM is expected to support project activities while onsite with the flexibility to coordinate meetings and travel to enable global time zone interactions dependent on project needs.
In partnership with the Technical Development Team Lead (TDTL) & Device Team Leader (DTL), the Project Manager (PM) will facilitate translation of the device strategy into a plan and drive execution at the Team level. The Project Manager responsibilities will focus in 3 key areas to enable execution of the device strategy within the agreed-upon constraints of scope, time and cost: 1) Facilitate effective planning with the Team to define “inspection ready” Design & Development Plans
2) Drive execution of Team activities to meet project and design control deliverables
3) Drive closure of Team actions to enable advancement to next stage through an effective Design Review process
The Project Manager is responsible for applying best practices, driving consistency, and facilitating effective communication to enable optimum Device Team performance in a regulated environment. A variety of processes and tools will be used to manage the information flow & meetings (communication), team dynamics, budget, schedule, compliance and project risk management. With these processes the PM will enable the Team to effectively perform in meeting their deliverables.
The PM will proactively drive planning and execution of the device design control strategy through the effective use of PM best practices and integration of Quality System Requirements (QSR) including design controls into Team activities. This will involve oversight of project plan execution through the close monitoring of critical path activities and the creation of contingency plans to resolve issues and achieve deliverables. The project plan will effectively integrate with the Technical Development Team (TDT) plan to meet schedule and budget requirements. The PM is responsible for promoting a collaborative team environment and maintaining positive team dynamics to enable on time execution. A strong emphasis on effective meeting management, transparent team communication, efficient decision-making, proactive risk management, conflict resolution and problem-solving is required.
Project Management: • Maintains full understanding of program milestones for the Core, Lifecycle, Technical Development and associated teams and links them to the Device Team plan
• Effectively applies PM best practices and utilizes tools for planning, communication, team building, collaboration, decision-making, issue & risk management, lessons learned, knowledge management and budget tracking o Develops & updates Design & Development Plan and establishes contingency plans as needed
o Ensures transparent communication of key team information and escalates issues as appropriate
o Establishes positive team dynamics through team building
o Promotes collaborative environment across team members
o Facilitates efficient decision-making and issue resolution
o Identifies team risks and mitigation plans Project Planning and Execution: • Proactively manages project and team to achieve deliverables and solve issues.
• Manages project scope and facilitates project changes as required
• Leads project plan development and execution
• Develops, monitors, and controls the detailed project schedule
• Drives change for improved efficiency and/or optimization
• Facilitates effective decision-making and escalation of issues
• Integrates project deliverables with other Teams linked to product (e.g. TDT)
• Integrates external collaborator plan(s) with Device Team project plan Project Issue and Risk Management: • Anticipates and manages risks efficiently using proactively defined contingency plans as appropriate
• Leads the Device Team project risk management process using the TDT Risk Management Tool
• Facilitates and lead Team issue and conflict resolution Collaboration and Team Building: • Assesses Team dynamics and leads team building activities to enable and sustain a high performing team environment
• Establish relationships and network with other stakeholder Teams and PMs Communication: • Develops and adapts project communication tools to drive awareness of project progress and risks across stakeholders including external collaborators (e.g. dashboard)
• Acts as Device Team Leader back-up for Team communication as required
• Liaises with other Teams to manage cross-functional activities and issues and risks Meeting Management: • Effectively facilitates Team meetings with meaningful desired outcomes, appropriate participants, minutes, actions and follow up
• Participates in CMO and Partner meetings and integrates relevant outcomes into project plan Budget and Resource Planning: • Actively forecasts and monitors Device Team resource (FTE) and project variable costs (PVCs) Knowledge Management: • Establishes centralized Team access to all relevant project information
• Manages Team uncontrolled document repository (e.g. Project History File)
• Conducts lessons learned exercises during project execution and share outcomes to a broader audience Governance: • Effectively navigates the Device Team through business process stage-gates
• Supports Team Leader with technical advisory and governance committee reviews at pre-defined check-in points and/or identifies appropriate check-in points Continuous Improvement Initiatives: • Leads business process continuous improvement initiatives through applying project lessons: business process updates, PM tool optimization & implementation, best practice sharing and driving awareness across teams. Quality System Requirements: • Effectively applies Quality System and Roche PQS requirements for team activities and deliverables
• Facilitates planning and maintains the Design and Development Plan (DDP) with Team input
• Oversees Design Review planning, execution and closure of actions and completes DHF records
• Effectively utilizes e-document system to maintain Design History File in compliance with PQS requirements
• Supports internal and health authority audits as required Education and Industry Experience: • B.S. or B.A degree, preferably in Engineering, or the equivalent.
• At least 8 to 11 years’ experience with at least 5 years relevant industry experience, preferably a multi-site global company in the medical device, pharmaceutical or biopharmaceutical, after receiving Bachelor’s degree
• Drug and/or Medical Device development & commercialization experience preferably with Combination Products Technical Knowledge: • Project Management best practices: communication, scheduling, budget & resource planning, team building and risk management
• PMP certification considered an asset
• Solid knowledge and understanding of 21CFR820.30 design control requirements
• Software tools: Microsoft Office (Project & Excel), Google, WebEx, Visio, Planisware Interpersonal: • Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment
• Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building) required
• Ability to effectively communicate in a highly matrixed organization and with external parties
Pay Rate Range: $100-130/hr. Salary will be commensurate with experience
The Device Development Project Manager (PM) will support 2 to 3 projects depending on the stage and complexity level of the program. Project assignments will include pipeline, product care, technology and/or continuous improvement initiatives. In this role the PM will work with limited direction and will effectively prioritize and manage their workload to meet Team goals. The PM is expected to support project activities while onsite with the flexibility to coordinate meetings and travel to enable global time zone interactions dependent on project needs.
In partnership with the Technical Development Team Lead (TDTL) & Device Team Leader (DTL), the Project Manager (PM) will facilitate translation of the device strategy into a plan and drive execution at the Team level. The Project Manager responsibilities will focus in 3 key areas to enable execution of the device strategy within the agreed-upon constraints of scope, time and cost: 1) Facilitate effective planning with the Team to define “inspection ready” Design & Development Plans
2) Drive execution of Team activities to meet project and design control deliverables
3) Drive closure of Team actions to enable advancement to next stage through an effective Design Review process
The Project Manager is responsible for applying best practices, driving consistency, and facilitating effective communication to enable optimum Device Team performance in a regulated environment. A variety of processes and tools will be used to manage the information flow & meetings (communication), team dynamics, budget, schedule, compliance and project risk management. With these processes the PM will enable the Team to effectively perform in meeting their deliverables.
The PM will proactively drive planning and execution of the device design control strategy through the effective use of PM best practices and integration of Quality System Requirements (QSR) including design controls into Team activities. This will involve oversight of project plan execution through the close monitoring of critical path activities and the creation of contingency plans to resolve issues and achieve deliverables. The project plan will effectively integrate with the Technical Development Team (TDT) plan to meet schedule and budget requirements. The PM is responsible for promoting a collaborative team environment and maintaining positive team dynamics to enable on time execution. A strong emphasis on effective meeting management, transparent team communication, efficient decision-making, proactive risk management, conflict resolution and problem-solving is required.
Project Management: • Maintains full understanding of program milestones for the Core, Lifecycle, Technical Development and associated teams and links them to the Device Team plan
• Effectively applies PM best practices and utilizes tools for planning, communication, team building, collaboration, decision-making, issue & risk management, lessons learned, knowledge management and budget tracking o Develops & updates Design & Development Plan and establishes contingency plans as needed
o Ensures transparent communication of key team information and escalates issues as appropriate
o Establishes positive team dynamics through team building
o Promotes collaborative environment across team members
o Facilitates efficient decision-making and issue resolution
o Identifies team risks and mitigation plans Project Planning and Execution: • Proactively manages project and team to achieve deliverables and solve issues.
• Manages project scope and facilitates project changes as required
• Leads project plan development and execution
• Develops, monitors, and controls the detailed project schedule
• Drives change for improved efficiency and/or optimization
• Facilitates effective decision-making and escalation of issues
• Integrates project deliverables with other Teams linked to product (e.g. TDT)
• Integrates external collaborator plan(s) with Device Team project plan Project Issue and Risk Management: • Anticipates and manages risks efficiently using proactively defined contingency plans as appropriate
• Leads the Device Team project risk management process using the TDT Risk Management Tool
• Facilitates and lead Team issue and conflict resolution Collaboration and Team Building: • Assesses Team dynamics and leads team building activities to enable and sustain a high performing team environment
• Establish relationships and network with other stakeholder Teams and PMs Communication: • Develops and adapts project communication tools to drive awareness of project progress and risks across stakeholders including external collaborators (e.g. dashboard)
• Acts as Device Team Leader back-up for Team communication as required
• Liaises with other Teams to manage cross-functional activities and issues and risks Meeting Management: • Effectively facilitates Team meetings with meaningful desired outcomes, appropriate participants, minutes, actions and follow up
• Participates in CMO and Partner meetings and integrates relevant outcomes into project plan Budget and Resource Planning: • Actively forecasts and monitors Device Team resource (FTE) and project variable costs (PVCs) Knowledge Management: • Establishes centralized Team access to all relevant project information
• Manages Team uncontrolled document repository (e.g. Project History File)
• Conducts lessons learned exercises during project execution and share outcomes to a broader audience Governance: • Effectively navigates the Device Team through business process stage-gates
• Supports Team Leader with technical advisory and governance committee reviews at pre-defined check-in points and/or identifies appropriate check-in points Continuous Improvement Initiatives: • Leads business process continuous improvement initiatives through applying project lessons: business process updates, PM tool optimization & implementation, best practice sharing and driving awareness across teams. Quality System Requirements: • Effectively applies Quality System and Roche PQS requirements for team activities and deliverables
• Facilitates planning and maintains the Design and Development Plan (DDP) with Team input
• Oversees Design Review planning, execution and closure of actions and completes DHF records
• Effectively utilizes e-document system to maintain Design History File in compliance with PQS requirements
• Supports internal and health authority audits as required Education and Industry Experience: • B.S. or B.A degree, preferably in Engineering, or the equivalent.
• At least 8 to 11 years’ experience with at least 5 years relevant industry experience, preferably a multi-site global company in the medical device, pharmaceutical or biopharmaceutical, after receiving Bachelor’s degree
• Drug and/or Medical Device development & commercialization experience preferably with Combination Products Technical Knowledge: • Project Management best practices: communication, scheduling, budget & resource planning, team building and risk management
• PMP certification considered an asset
• Solid knowledge and understanding of 21CFR820.30 design control requirements
• Software tools: Microsoft Office (Project & Excel), Google, WebEx, Visio, Planisware Interpersonal: • Demonstrated ability to work independently to manage complex projects with multiple priorities in a fast-paced, ever-changing, team-based environment
• Excellent oral and written communication skills (listening, negotiation, presentation, organizational and relationship-building) required
• Ability to effectively communicate in a highly matrixed organization and with external parties
Pay Rate Range: $100-130/hr. Salary will be commensurate with experience
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