Hybrid Director, Quality Product Strategy – Devices

at MSD

• Job title: Director, Quality Product Strategy – Devices
• Job type: Full Time
• Experience level: Lead
• Salary: $173,200 - $272,600 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Rahway, United States

About the role

• Director of Quality Product Strategy for pharmaceutical product strategy overseeing manufacturing and testing network quality strategies. Collaborating across teams to ensure product launch and supply strategies are in place.

Responsibilities

• 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