About this role
Role Overview
- supports the end-to-end pharmaceutical product strategy in our manufacturing and testing network
- ensures development and execution of a robust quality strategy for products supporting launch of the pipeline and/or uninterrupted supply of commercial products
- leads development and oversight of the Product Quality Strategic elements for the pharmaceutical franchises that includes short and long-term goals for the product franchise in alignment with the DCT/VCMT/Platform Councils/Product Councils
- acts as a quality designee for global product quality as needed
- ensures prioritization, progress, and escalation, as appropriate, of quality related strategic goals through periodic reviews and dashboards across products and manufacturing/testing sites across the network
- leads and/or participates in executing the VCMT/DCT aligned strategic goals with stakeholders and partners across our Research & Development Division and our Manufacturing Division
- reviews and approves franchise level documentation including Comparability Plans, CPV plans, Sister Site Evaluations, Post Marketing Product Reviews, Annual Management Review, Control Strategies, franchise level protocols/reports, filing/license submissions, franchise level regulatory observation responses, RTQs, franchise level change control, site and multi-site investigations, where appropriate
Requirements
- Bachelor’s Degree (BA/BS) with a concentration in Sciences or Logistics
- minimum of twelve (12) years of experience including quality oversight roles including technical elements or technical operations roles
- minimum of 2 years direct experience with supply chain strategy or technical elements (e.g. change controls, investigations, process documentation (e.g. protocols, CPV, etc.), preferably with small molecule products
- demonstrated skills for external facing communications in written and verbal form
- demonstrated success leading multi-functional teams driving continuous improvement and execution of strategic actions across a network (i.e. multiple groups/sites/functions)
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays, vacation, and compassionate and sick days