Werfen
Senior Project Manager
Werfen, San Diego, California, United States, 92189
Job Summary
The Senior Project Manager position is a senior position within the Autoimmunity Project Management Office (PMO). This position has strategic responsibility for leading cross-functional teams for effective management of all aspects of assigned projects. The Senior Project Manager acts as a liaison between the core project team and stakeholders to drive visibility, accountability, and cross-functional task execution, in alignment with the project plan. Responsible for driving high performance, solution-oriented, and collaborative project teams that foster agility, innovation, trust, and communication.From a tactical perspective, the Senior Project Manager is responsible for managing multiple large-sized projects, usually of medium to high complexity, for either the development of new or improved Autoimmunity diagnostics products, or related to life-cycle management of the existing portfolio of Autoimmunity products. All work will be performed in accordance with Autoimmunity standard operating procedures and within all Quality Systems, Legal, and Human Resource regulations.Responsibilities
Key AccountabilitiesLeads multiple large-sized projects (projects can be part of either one or multiple Programs), usually of high complexity, for either the development of new or improved Autoimmunity diagnostics products or related to life-cycle management of Autoimmunity existing portfolio of products.Leads cross-functional project teams, that might contain representation from multiple departments and disciplines; ensures all project deliverables are delivered with exceptional quality, within scope, time, and At times, project team members may include employees from other Werfen entities or could be external partners, vendors, and/or consultants.Accountable for creation and monitoring of necessary project management artifacts, i.e., project plan(s), resource management plan(s), communication plan(s), project budget, and schedules,For new development, accountable for establishing and maintaining the Design History File (DHF) for the assigned project(s). Properly, verifies the Design Control Records, laboratory notebooks, and any associated documentation for all Research and Development activities.For Design Changes, accountable for managing all the necessary steps for the successful completion of the change(s) according to established procedures and work instructions.Ensures all documentation and testing needs are met, including but not limited to manuals, labeling, training materials or other documents for the successful launch of the new product or successful implementation of a new process.As applicable, accountable for managing the overall relationship with external partners and/or consultants during the development, testing and transfer phases of Also, accountable for managing, tracking and reporting against the approved vendor budget.Provides guidance, training, mentorship, and coaching to junior members of the team and potentially other aspiring project managers within the organization.Stays current on project management tools, processes; recommends and implements changes to increase the performance of the Project Management team.Evaluates department processes, tools, and operations. Makes recommendations for improvements to department management.Supports department budget indirectly by managing expenses effectively and provides the necessary input(s) for estimating and planning of departmentComplies with applicable Autoimmunity standard operating procedures (SOPs), ISO, FDA and other Quality System Regulations (QSR), as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.Reflects the Werfen Values in the quality of work and in establishing and maintaining working relationshipsQualifications
Minimum Knowledge & Experience required for the positionEducationBachelor's degree in science in Biology, Microbiology, Cellular Biology, Biochemistry, Computer Science, Software Engineering, Engineering (i.e., Electrical Engineering, Mechanical Engineering, etc.) or a similar field of study required.Project Management Professional (PMP) certification required.Experience8+ years running large and complex project management experience required, in research and/or life sciences or a pharmaceutical environment highly preferred.8+ years laboratory experience required, in life sciences, autoimmunity, or medical devices preferred.Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.Skills & CapabilitiesAdvanced skills in planning and managing complex projects, including agility to adjust in real-time to ensure success.Advanced understanding of formal project management methodologies.Exceptional ability to plan and meet project timelines and project budgets.Ability to thrive within a fast-paced environment.Advanced skills at developing and delivering presentations and training.Exceptional communication, negotiation, influencing, and emotional intelligence skills.Able to influence others in critical situations and resolve conflict.Keen attention to detail.Advanced knowledge of Microsoft products, including Microsoft Project required.Travel requirementsLess than 10% of the time.
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The Senior Project Manager position is a senior position within the Autoimmunity Project Management Office (PMO). This position has strategic responsibility for leading cross-functional teams for effective management of all aspects of assigned projects. The Senior Project Manager acts as a liaison between the core project team and stakeholders to drive visibility, accountability, and cross-functional task execution, in alignment with the project plan. Responsible for driving high performance, solution-oriented, and collaborative project teams that foster agility, innovation, trust, and communication.From a tactical perspective, the Senior Project Manager is responsible for managing multiple large-sized projects, usually of medium to high complexity, for either the development of new or improved Autoimmunity diagnostics products, or related to life-cycle management of the existing portfolio of Autoimmunity products. All work will be performed in accordance with Autoimmunity standard operating procedures and within all Quality Systems, Legal, and Human Resource regulations.Responsibilities
Key AccountabilitiesLeads multiple large-sized projects (projects can be part of either one or multiple Programs), usually of high complexity, for either the development of new or improved Autoimmunity diagnostics products or related to life-cycle management of Autoimmunity existing portfolio of products.Leads cross-functional project teams, that might contain representation from multiple departments and disciplines; ensures all project deliverables are delivered with exceptional quality, within scope, time, and At times, project team members may include employees from other Werfen entities or could be external partners, vendors, and/or consultants.Accountable for creation and monitoring of necessary project management artifacts, i.e., project plan(s), resource management plan(s), communication plan(s), project budget, and schedules,For new development, accountable for establishing and maintaining the Design History File (DHF) for the assigned project(s). Properly, verifies the Design Control Records, laboratory notebooks, and any associated documentation for all Research and Development activities.For Design Changes, accountable for managing all the necessary steps for the successful completion of the change(s) according to established procedures and work instructions.Ensures all documentation and testing needs are met, including but not limited to manuals, labeling, training materials or other documents for the successful launch of the new product or successful implementation of a new process.As applicable, accountable for managing the overall relationship with external partners and/or consultants during the development, testing and transfer phases of Also, accountable for managing, tracking and reporting against the approved vendor budget.Provides guidance, training, mentorship, and coaching to junior members of the team and potentially other aspiring project managers within the organization.Stays current on project management tools, processes; recommends and implements changes to increase the performance of the Project Management team.Evaluates department processes, tools, and operations. Makes recommendations for improvements to department management.Supports department budget indirectly by managing expenses effectively and provides the necessary input(s) for estimating and planning of departmentComplies with applicable Autoimmunity standard operating procedures (SOPs), ISO, FDA and other Quality System Regulations (QSR), as well as applicable Environmental Health & Safety, Human Resources and all other regulatory and administrative policies.Reflects the Werfen Values in the quality of work and in establishing and maintaining working relationshipsQualifications
Minimum Knowledge & Experience required for the positionEducationBachelor's degree in science in Biology, Microbiology, Cellular Biology, Biochemistry, Computer Science, Software Engineering, Engineering (i.e., Electrical Engineering, Mechanical Engineering, etc.) or a similar field of study required.Project Management Professional (PMP) certification required.Experience8+ years running large and complex project management experience required, in research and/or life sciences or a pharmaceutical environment highly preferred.8+ years laboratory experience required, in life sciences, autoimmunity, or medical devices preferred.Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.Skills & CapabilitiesAdvanced skills in planning and managing complex projects, including agility to adjust in real-time to ensure success.Advanced understanding of formal project management methodologies.Exceptional ability to plan and meet project timelines and project budgets.Ability to thrive within a fast-paced environment.Advanced skills at developing and delivering presentations and training.Exceptional communication, negotiation, influencing, and emotional intelligence skills.Able to influence others in critical situations and resolve conflict.Keen attention to detail.Advanced knowledge of Microsoft products, including Microsoft Project required.Travel requirementsLess than 10% of the time.
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