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Project Manager Product Variation Lead (Jp4738)

Expired Job

3 Key Consulting Thousand Oaks , CA 91320

Posted 3 days ago

Job Title:Project Manager Product Variation Lead (JP4738)
Job Site:Thousand Oaks, Ca.
Type: Contract
Duration: 6 months
Business Unit: GSC Global Supply Chain
3Key Consulting Inc. is looking for role for a Project Manager with strong project management skills, financial analysis, supply chain, and background in biotech industry, for a global, CA-based, bio-pharmaceutical company.
Description:
Role Overview:
Effective management of post-launch changes to products variations is critical. This is especially true given the continued forecasted growth in product portfolio and international expansion. Drivers of product change are quite varied and include but are not limited to: response to patient safety issues, regulatory commitments, addressing supply requirements, manufacturing network strategy, commercial or regional strategy, labeling changes, and operational excellence projects.
The Variation Lead will be accountable for driving the cross-functional execution of a portfolio of variation projects for commercial products. Holistically, this group will be focused on robust project, portfolio, and process management for variations to capture and accelerate the value of change to our commercial products.
The scope of the variation management process includes: business case approval for a change, variation portfolio prioritization, change control, supply and submission planning, and project execution through approval from global regulatory agencies and implementation into the supply chain.
Basic Qualifications:
Masters degree OR
Bachelors degree & 2 years of Operations or Regulatory experience OR
Associates degree & 4 years of Operations or Regulatory experience
6 + years biotech or pharmaceutical industry experience
Able to facilitate and influence senior clients and partners
Able to successfully manage workload to timelines
Familiarity with basic project management tools
Ability to negotiate a strategic position after taking feedback from multiple sources
Periodic travel to sites required up to 10%.
Preferred Qualifications:
  • Strong project management, problem-solving, and analytical skills; experience with project management tools
  • Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
  • Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Comfortable in start-up environment of a new Amgen group
  • Experience driving decision making
  • Some experience with a variation management process
Top Must Have Skill Sets:
1. Project Planning/Financial Analysis (Business Case Development)
2. Drug substance/drug product and/or combination product experience
3. Ability to work with a cross-functional team
Day to Day Responsibilities:

Key Responsibilities:
  • Represent Variation Management Organization (VMO) on Product Delivery Teams (PDTs), guide stakeholders through the process and assist with business case development
  • Lead cross-functional stakeholders in development of global variation project plans
  • Drive end-to-end execution of a PDTs portfolio of variation projects (from business case through global regulatory approvals)
  • Communicate priorities to product, functional, and regional stakeholders, identify and resolve issues, escalate to appropriate governance as needed
  • Adhere to processes and best practices set by Business Process Owner, drive continuous improvement of processes
  • Shepard variations through governance process
  • Standardize and integrate project management tools; establish single source of truth for variation status
Employee Value Proposition:
This role provides the External Worker an opportunity to quickly gain experience on a variety of projects such as regulatory commitments, manufacturing network strategies, supply assurance, product and process improvements, etc. They will also gain exposure to different functions such as Supply Chain, Regulatory, Manufacturing, Quality, and Process Development (e.g. drug substance, drug product, analytical sciences, combination products). The External Worker guides the team through business case generation, project planning, and execution, and through this work has the prospect of influencing the teams strategy for large commercial products.
Red Flags:
  1. Lack of biotech/medical device experience
  2. Not looking for IT, banking, automotive, etc.
Interview Process:
Phone followed by in-person panel interview.
We invite qualified candidates to sendyour resume toresumes@3keyconsulting.com. Ifyou decide that youre not interested in pursuing this particular position, please feel free to take a look at the other positions on our websitewww.3keyconsulting.com. You are also welcome to sharethis posting withanyone you think might be interested in applying for this role.
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Project Manager Product Variation Lead (Jp4738)

Expired Job

3 Key Consulting