Associate Director, Quality Planner.

6 days ago

india 3M Consultancy Full time
Job Description
Job Title: Associate Director, Quality Planner.
Location: Novato, CA.
Duration: Permanent.
Role Responsibilities:
Work with various stakeholders to identify how to consistently quantify demand within QC and QA organizations
Define a Process to ensure demand requirements are updated regularly 
Have a month-on-month demand plan, for the long-term planning zone  
Build a capacity model, Graphical representation of capacity vrs demand, identify month on month what are the drivers for demand, identify where deltas exist. 
Within this model incorporate the asks for project resources and support to ongoing business activities. 
Host a monthly Quality Capacity Planning Meeting to determine what actions can be taken within the Quality group to reduce the deltas. 
Establish process with key stakeholders from QA, Supply Chain, QC, manufacturing etc. to align the rolling look-ahead, Release Commitment dates, and plan QA/QC capacity accordingly.   
Act as Quality Single Point of Contact (SPOC) for all Lot Release & testing Planning and Prioritization activities and provide guidance and clear direction to the functions as necessary to enable successful delivery of the plan. 
Ensure that the planning and execution of QC testing, QA release meets the supply planning schedule requirements  
Implement batch tracking /monitoring for each step in the process, flagging any issues early and communicate to impacted groups.  i.e. if lead time is being missed by any party. 
Prioritize QC Testing/Sampling/Batch Record Review/ Batch Release/ Label Implementation Planning etc. in alignment with Supply Chain Planning to ensure no stock outs, while level loading workflow versus available resources.
Ensure data accuracy in Oracle (e.g. Lot release lead times) for key planning parameters. 
Maintain tracking files and highlight potential delays, i.e. OOS causing a lead time miss, working on CAPAs with partners to avoid issues re-occurring, etc.  
Manage the handoffs and communications with key stakeholders / functions to establish and maintain visibility, alignment and adherence to the plan. 
Facilitate regular status update meetings with key stakeholders. 
Support /drive improvement projects in line with business needs to optimize the Make, Assess, Release
Run performance reports and calculate weekly and monthly metrics for site Quality performance  
Negotiate and manage SLAs with key customers as required.  
Support budget preparation and monitoring, capacity planning, calculation of batch numbers, monitoring spend versus budget, latest estimate etc.             
Requirements
Education Required:
B.S. with at least 6-10 years’ experience in a relevant functional area (at least 2 years in Quality Control and/or Quality Assurance).
Experience Required:
At least two years in a cGMP laboratory, Quality Control experience preferred.
Operational Excellence (ex.Lean Six Sigma certification) experience preferred
Ability to work independently, managing projects and meeting established timelines.
Computer literacy is required. Experience with Information Management systems (i.e., LIMS, BINOCS, PowerBI) is preferred.
Requirements
Education Required: B.S. with at least 6-10 years’ experience in a relevant functional area (at least 2 years in Quality Control and/or Quality Assurance). Experience Required: At least two years in a cGMP laboratory, Quality Control experience preferred. Operational Excellence (ex.Lean Six Sigma certification) experience preferred Ability to work independently, managing projects and meeting established timelines. Computer literacy is required. Experience with Information Management systems (i.e., LIMS, BINOCS, PowerBI) is preferred.

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