MSD

Director, Quality Product Strategy – Devices

MSD

full-time

Posted on:

Location Type: Hybrid

Location: Rahway • New Jersey • New York • United States

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Salary

💰 $173,200 - $272,600 per year

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality strategyproduct quality oversightsupply chain strategychange controlsinvestigationsprocess documentationcomparability plansCPV plansregulatory observation responsesmulti-site investigations
Soft Skills
external facing communicationswritten communicationverbal communicationleading multi-functional teamsdriving continuous improvementexecution of strategic actions
Certifications
Bachelor’s Degree in Sciences or Logistics