Day to Day Responsibilities
" Follow the Quality guideline (QCM01-01-001-G001) and serve as the Change Owner and drive both the set-up and completion of the Change Plans for Key Product Life Cycle activity. (i.e. product discontinuations)
" Work with the Operations Brand Managers and the full Cross Functional Team (CFT) to identify all critical information needed for the Change Plan (CP) (timing, full scope, specific product information, name of the Supply Chain Planner, etc.)
" Set up Project Planning meetings, invite key areas listed in the guideline (and know who to contact for the meeting)
" During the meeting(s)
o Discuss the key topics listed in the Quality guideline (scope, timing, impact to sites/affiliates....)
o Request action items (information needed to populate the Change Plan and tasks) from the core Cross Functional Team (CFT) and follow up if they do not provide the information
o Go through the Potential task list with the team to determine which tasks would be needed for the CP
o Request the team identify the main information for each task (Task Owner, Task Approver, Task due date)
" Populate the Change Plan per QCM01-01-001 (with specific examples and guidance from QCM01-01-001-G001). Basically, every field other than Regulatory, would be filled out by the Change Owner, and ALL tasks identified would also be created
" Perform all activities in the guideline that may be needed (example: submit a help desk ticket to get a MARC table with all information that would be in the SAP Grid)
" Submit the CP to the Change Coordinator in SolTRAQs (We review and if complete, get Reg assessment, discuss with the CRB for preapproval, set up a CFT meeting to review everything and determine if there are more tasks information needed, route the CP, etc.)
" Attend CRB meetings where applicable to explain CP to the board and follow-up on any questions that may come out of those meetings
" Follow up with the approvers and task owners if they do not close out their activities in time
" Manage the status (A0, A3, A4, A5) of the SAP codes in scope of the CP and work with Master Data Management to ensure the status is updated timely
" Are you open to look at candidates willing to relocate? No,
" Years of experience/education and/or certifications required: BS degree or 4-8 years equivalent experience
" What are the top 3-5 skills requirements should this person have?
1: Experienced in project mangement
2: Demonstrated ability in leading cross-functional teams
3: Ability to independently perform Quality System (SOLTRAQS) documentation and SAP capabilities helpful
4: Excellent organizational skills, attention to detail, and strong oral and written communications skills
" What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
o Bachelor of Science; 4 year pharma, health care, or regulated industry
" What type of environment is this person working in?
o Group setting
o Individual Setting
o Combination of both
" Work Schedule (Define days,# of hours)/ Is Overtime offered or required? If yes, how many hours, what impact to scheduled working hours?
o 5 days/week Mon-Fri, 40 hours with flexibility on exact hours/day
" Does this position offer the ability to work remotely on a regular basis or is it an on-site role? If remote opportunity exists, what are the options (i.e. 1 day remote, 4 days on-site)?
o Combination of remote and in-person Lake County IL. 1-2 days on-site. 3-4 days remote
" Will there be Domestic and/or International Travel? If yes, list proposed countries and % of time travelling:
o No travel required