4 дня назад
Director, Commercial Quality-Packaging and Labeling (Pharmaceutical)
184 600 - 277 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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