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Notable Outcomes:

  • Improved performance assessments, clearer succession plans, promotable employee alignment, High Potential recognition

  • Customized learning paths with transparent sharing of plans with Leadership

  • Enhanced technical expertise along with Improved interpersonal and business acumen

  • Constructive Leader and Employee feedback exchanges

 

4. Have a Future:  Career development ladder 

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Talent Calibrations: 9-panel calibration at Midyear (Results-Potential) and End of Year (Results - Leadership), Succession Planning, High Potential + Promotables identification, department capability status, and HR talent key measures.  Templates have detailed explanations to assist leaders in completing.  Important is to utilize a tiered leadership process that includes input and calibration discussions from Supervisor up through Site Leaders.

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Learning Development Deep Dives  is a simple process with outcome (i) Employee develops learning development plan with input from respective leader, (ii) Plan is presented by Employee to Leadership team for constructive feedback.   Employee <-> Manager <-> LT in Employee Development

Periodic lunch time learning sessions focused on various leadership topics.  This is an interactive session that typically starts with real time group poll, volunteers discussing success/challenges related to implementing prior session topic, a couple of slides on the new topic with implementation insights, and then closeout poll to demonstrate learning.  Facilitation is rotated amongst leaders.

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Process aide to facilitate On the Job training.  This should align with system of record QMS, has 30-60-90 day onboarding plan,  and will also include soft skills training.

​Additional:

  • 5 Annual Discussions- (i) Annual Performance Calibration, (ii) Merit Review, (iii) G&O, (iv) Mid-Year Review, (v) Annual Learning Development Deep Dive

  • Periodic review of recognition program (utilization, consistency, value), staffing requisition status, hiring trends, rotating topics

Capability Building Training

  • cGMP Essentials + One Point Lessons

  • Leadership Development: FLL, Coaching

  • Lean/ 6s /5S + Basic Statistics

  • Project Management Essentials

  • CDMO Order to Release SIPOC +M

  • Aseptic Manufacturing Principles

  • Problem Solving

  • CAPA Owner Training

  • Audit/Inspections Do’s and Don’ts

  • ICH Overview

  • USP Overview

  • FDA Guidance Overview

  • EMA Overview

  • Regulations:

  • Quality by Design (QbD)

  • Phase Appropriate Drug Development

  • CMC, Drug Substance (CTD S1-S7)

  • CMC, Drug Product (CTD P1-P7)

  • Analytical Method Development Basics

  • Technology Transfers

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