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"Job Requirements of Project Manager - I*:"
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Employment Type:
Full-Time
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Experience:
Not Specified
-
Education:
Not Specified
-
Travel:
Not Specified
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Manage Others:
Not Specified
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Location:
Santa Monica, CA (Onsite)
Do you meet the requirements for this job?
Project Manager - I*
Integrated Resources, Inc
Santa Monica, CA (Onsite)
Full-Time
Pay Rate: $73.33/Hr on W2
Job Description:
Product Variation Management (PVM) Lead will manage the business and system processes for managing product variations.
As Client expands to more products, global jurisdictions and manufacturing sites, changes increase in complexity and the number of product lifecycle changes that require variation management and jurisdictional control (JC) is proliferating.
The PVM Lead will manage the global cross functional PVM team and JC business processes, and ensure, from an end-to-end planning and execution perspective, that the right product version is supplied to the right jurisdiction at the right time, in line with the regulatory filing strategy and global implementation plan.
The product variation planning process is complex and oversees changes end-to-end, from regulatory filing to global and regional planning, and to manufacturing site implementation.
Responsibilities: (include but are not limited to):
Lead a cross-functional matrix global PVM planning team that spans across all Technical Operations functions, IT, and Clinical Logistics
Own and manage the business process for managing product variations
Manage change management and communication of the new business process
Lead team meetings, manage the global PVM tracking tools, and monitor PVM and JC metrics
Responsible for overseeing product variations from strategy definition through implementation across all impacted jurisdictions and manufacturing sites
Collaborate with cross functional stakeholders globally, considering interdependencies across Tech Ops, manufacturing network, and other stakeholders as needed
Facilitate cross-functional SME assessment of product variation changes to determine the plan for implementation
Liaise between the global PVM planning team and the governance bodies responsible for product variation and lifecycle management strategy definition, for alignment between strategy and implementation rollout plan
Deep dive into functional areas and manufacturing site processes to understand complexities, interdependencies, risks, and facilitate alignment across functions
Monitor status of change control(s) enabling a variation s implementation globally from initiation to approval to implement; change control ownership possible based on type of change
Qualifications, Skills & Experience: BS degree required, concentration in science / engineering / business management is a plus
Master's Degree and 3-5 years of operations or supply chain experience in life sciences industry or Bachelor's Degree and 5-7 years of operations or supply chain experience in life sciences industry
Experience in working with ERP business systems (preferably Oracle EBS)
Diverse experience in operations disciplines
Exceptional ability to communicate and collaborate across different stakeholders
Ability to operate at different levels, both strategically and tactically
Proven success in leading cross functional teams and ability to influence all levels of staff in a matrix organization
Experience in Project Management and / or with PM tools such as SmartSheet is a plus
Drive to seek clarity and think critically
Excellent verbal, and written communication skills, including presentations
Ability to manage ambiguity and simplify complexity
Ability to navigate competing interests to achieve a common solution that is aligned across different parties
Ability to learn quickly, and absorb and simplify information from multiple sources; connect the dots into a cohesive plan
Self-directed and able to work independently with minimal direction
Works well in a dynamic, fast-changing environment
Enthusiastic team player
Job Description:
Product Variation Management (PVM) Lead will manage the business and system processes for managing product variations.
As Client expands to more products, global jurisdictions and manufacturing sites, changes increase in complexity and the number of product lifecycle changes that require variation management and jurisdictional control (JC) is proliferating.
The PVM Lead will manage the global cross functional PVM team and JC business processes, and ensure, from an end-to-end planning and execution perspective, that the right product version is supplied to the right jurisdiction at the right time, in line with the regulatory filing strategy and global implementation plan.
The product variation planning process is complex and oversees changes end-to-end, from regulatory filing to global and regional planning, and to manufacturing site implementation.
Responsibilities: (include but are not limited to):
Lead a cross-functional matrix global PVM planning team that spans across all Technical Operations functions, IT, and Clinical Logistics
Own and manage the business process for managing product variations
Manage change management and communication of the new business process
Lead team meetings, manage the global PVM tracking tools, and monitor PVM and JC metrics
Responsible for overseeing product variations from strategy definition through implementation across all impacted jurisdictions and manufacturing sites
Collaborate with cross functional stakeholders globally, considering interdependencies across Tech Ops, manufacturing network, and other stakeholders as needed
Facilitate cross-functional SME assessment of product variation changes to determine the plan for implementation
Liaise between the global PVM planning team and the governance bodies responsible for product variation and lifecycle management strategy definition, for alignment between strategy and implementation rollout plan
Deep dive into functional areas and manufacturing site processes to understand complexities, interdependencies, risks, and facilitate alignment across functions
Monitor status of change control(s) enabling a variation s implementation globally from initiation to approval to implement; change control ownership possible based on type of change
Qualifications, Skills & Experience: BS degree required, concentration in science / engineering / business management is a plus
Master's Degree and 3-5 years of operations or supply chain experience in life sciences industry or Bachelor's Degree and 5-7 years of operations or supply chain experience in life sciences industry
Experience in working with ERP business systems (preferably Oracle EBS)
Diverse experience in operations disciplines
Exceptional ability to communicate and collaborate across different stakeholders
Ability to operate at different levels, both strategically and tactically
Proven success in leading cross functional teams and ability to influence all levels of staff in a matrix organization
Experience in Project Management and / or with PM tools such as SmartSheet is a plus
Drive to seek clarity and think critically
Excellent verbal, and written communication skills, including presentations
Ability to manage ambiguity and simplify complexity
Ability to navigate competing interests to achieve a common solution that is aligned across different parties
Ability to learn quickly, and absorb and simplify information from multiple sources; connect the dots into a cohesive plan
Self-directed and able to work independently with minimal direction
Works well in a dynamic, fast-changing environment
Enthusiastic team player
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