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4 дня назад

Director, Commercial Quality-Packaging and Labeling (Pharmaceutical)

184 600 - 277 000$
Формат работы
hybrid/onsite
Тип работы
fulltime
Грейд
director
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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TL;DR
Director, Commercial Quality-Packaging and Labeling (Pharmaceutical): Leading commercial resupply and lifecycle quality operations for primary and secondary packaging and labeling across a global CMO network with an accent on GMP/GDP compliance, risk-based oversight, and business continuity. Focus on building quality governance, resolving escalated quality events, strengthening team capability, and coordinating cross-functional release and supply activities.

Location: Boston, MA, United States; hybrid work up to two days remotely per week or on-site five days per week.

Base salary: $184,600–$277,000 per year, plus eligibility for annual bonus and equity awards.

Company

Vertex is a global biotechnology company focused on scientific innovation and medicines for patients.

What you will do

  • Lead operational quality oversight for commercial resupply and lifecycle management of primary and secondary packaging and labeling across US and UK/EU CMOs.
  • Translate strategy and business priorities into quality plans, resource priorities, governance, and execution expectations.
  • Lead escalation, triage, risk assessment, investigation, CAPA, change control, batch documentation review, and disposition activities.
  • Coordinate cross-functional forums with Quality, Manufacturing and Technical Operations, Supply Chain, Regulatory, Launch/Technical Quality, CMOs, and Qualified Persons.
  • Monitor quality metrics and KPIs, support management reviews, and maintain inspection and audit readiness.
  • Build team capability through people leadership, coaching, performance management, succession planning, and operating-model improvements.

Requirements

  • Bachelor’s degree in a scientific or allied health field, or equivalent education.
  • 10+ years of relevant experience and 4+ years of management experience, or an equivalent combination.
  • Experience leading managers and senior professionals in a complex GMP environment.
  • Strong knowledge of global GMP/GDP requirements and commercial pharmaceutical packaging and labeling operations.
  • Experience applying risk-based quality principles, managing escalations, and supporting release-related activities.
  • Knowledge of packaging and labeling requirements across the US, EU, and other global markets, with strong communication and cross-functional leadership skills.

Nice to have

  • Experience with Operational Excellence methods, root cause analysis, and continuous improvement.
  • Experience supporting commercial small-molecule, biologic, or combination-device product lines.

Culture & Benefits

  • Continuous learning and access to advances in AI, technology, automation, and industry trends.
  • Medical, dental, and vision benefits with paid time off and seasonal company shutdowns.
  • Educational assistance, student loan repayment support, commuting subsidy, charitable donation matching, and 401(k).
  • Inclusive workplace with equal employment opportunity and reasonable accommodation support.

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