Senior Manager NPL

Job Title: Senior Manager NPL (New Product Launch) and LCM (Life Cycle Management)

Work Location: Bridgeton, MO

Education/Experience Required: 7 + years of progressive experience in project management (or the application and oversight of control points e.g. finance, QA) in a shared-services environment

Job Description & Responsibilities :

Lead (and act as an individual contributor to) the packaging, label and project management team responsible for coordinating and tracking activities for NPL and LCM. The aim is to assure the optimal time to market for all NPL and LCM projects in line with the objectives of the business and in compliance with the relevant regulations. For clarity the scope includes US NPL/LCM products coming from EU/ROW and those US manufactured NPL/LCM products that are destined for Ex-US affiliates.

Accountability 1 – Project Manager for the NPL and LCM of US Manufactured Products destined Ex-US

• Act as (Managerial) oversight to or as the Project Manager for all NPLs and LCMs where client is the manufacturer of products for affiliates outside of North America.
• Working with: the project DRI (Directly Responsible Individual) ; relevant US functions (R&D, R&D Project Management; Industrial Operations; MSAT; finance; Regulatory Affairs; packaging and labelling); and, the CReA HQ team, delineate the optimal path, plans and time to market for Products manufactured in the United States that are destined for markets outside of the United States.
• Using the project management tools (PPM Pro) available, monitor and track the progress of projects and ensure that risks to timelines are noted and issues escalated to US management and communicated to the CReA HQ project lead.

Expected Results: US Manufactured Products destined Ex-US are launched with zero defect, sufficient quantities to cover a minimum of 6 months of forecasted sales and an optimal time to market (as delineated by the business and in compliance with regulations) . Packaging and Label inventories for the Ex-US affiliates are well managed with minimal destruction outside of regulatory based changes and no back-orders are linked to the change of packaging for LCM products.

Accountability 2 – Manage the Packaging, Labelling and IDS (Item Data Setup) team

• Provide leadership and management support to the Packaging and Labelling team.
• Ensure that the packaging, labelling and IDS processes are optimal.
• Ensure that the packaging, labelling and IDS processes are monitored with applicable KPIs so the performance can be monitored and tracked.
• Packaging and label inventories are optimally managed with limited destruction.
• Manage any outside contractors (and associated budgets) that are required for labelling e.g. graphic design resources.

Expected Results: Packaging and product labels are ready for NPL and LCM with zero defect and an optimal time to market (as delineated by the business and in compliance with regulations). Packaging and Label inventories are well managed with minimal destruction outside of regulatory based changes and no back-orders are linked to the change of packaging for LCM products.

Accountability 3 – Provide leadership and management support for US based Project Managers

• Provide leadership and management support to the CReA project managers; ensure all appointed projects adhere to the best practices and standard approaches for project management.
• Ensure directly or through the CReA PM team that the in-house project management tools are well maintained and appropriately leveraged by the business.
• With senior management in NA and with CReA HQ, identify the future (12-24 months) NPLs that will comprise the workload for the Packaging, Labelling, IDS and Project Management team; set out a framework for the resources that will be applied.
• With senior management in NA, identify the future outsourced R&D projects that will require CReA PMO oversight and set out a framework for the resources that will be applied.

Expected Results: US Products are launched with zero defect, sufficient quantities to cover a minimum of 6 months of forecasted sales and an optimal time to market (as delineated by the business and in compliance with regulations) .

Accountability 4 – Provide Project Management for US projects

• As availability permits, act as Project Manager for NPL in the United States.
• Working with: the project DRI (Directly Responsible Individual) and relevant US functions (R&D, R&D Project Management; Industrial Operations; MSAT; finance; Regulatory Affairs; packaging and labelling); and, the CReA HQ team, delineate the optimal path, plans and time to market for the assigned Product
• Using the project management tools (PPM Pro) available, monitor and track the progress of projects and ensure that risks to timelines are noted and issues escalated to US management.

Expected Results: US Products are launched with zero defect, sufficient quantities to cover a minimum of 6 months of forecasted sales and an optimal time to market as delineated by the business and in compliance with regulations.

Accountability 5 - Management of the team

• Within the framework of the policies and procedures of Direct and manage a team that operates from multiple locations including home-office based
• Build and develop teams that are aligned to business strategy and drives medium and long term
• Prepare succession planning for critical roles within the NPL/LCM (CReA) organization

Expected Results: Optimal performance of the team, skills development of personnel, and application of the GPTW (Great Place to Work) principles.

Skills & Qualifications :

Behaviors / Knowhow - Interpersonal skills required to complete activities

• Sound business judgment, with an ability to think strategically and give practical advice.
• Outstanding oral and written communication skills, with the ability to communicate complex subjects to managers and executives.
• Creative, resilient and flexible style and approach to complex project modeling and analysis tailored to the relevant audience.
• Integrity and the ability to maintain confidentiality.
• The ability and desire to work with diverse teams in meeting corporate (global) and US Regional goals and objectives. Willingness to travel in the US and globally as needed, sometimes with little notice.
• Languages: Proficient in English (Any level French proficiency a plus)

(Preferred) Training Experience

• 7 + years of progressive experience in project management (or the application and oversight of control points e.g. finance, QA) in a shared-services environment
• 2 + years experience in pharmaceutical regulatory environment
• Experience in pharmaceutical manufacturing environment but not required
• Experience in enterprise project management software – (preferred tool) PPM Pro by Planview + MS Project
• Project Management Professional (PMP) certification and/or equivalent business experience
• 4 year degree in Business, Finance, Engineering, Life Sciences or other similar more quantitative discipline

Cross-Functional Relationships: which may impact the job's activities

Internal:

• Operational Management (Commercial Operations, Industrial Operations, Innovation Operations)
• CReA HQ
• All areas of Organization, including Corporate and affiliates in other countries
• Global and North American R&D teams
• North America Executive Board
• IT

External

• Vendors, customers, third party manufacturing, CROs
• Industry peers - networking to internalize best Project Management practices