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