10 дней назад
Senior Manager, Supplier Quality Operations
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Supplier Quality Operations (Pharmaceutical Manufacturing): Leading supplier quality strategy, compliance, and performance across U.S. manufacturing sites and global supply networks with an accent on FDA requirements, supplier risk management, and operational continuity. Focus on directing regulatory inspection readiness, resolving supplier deviations, improving vendor performance, and deploying global quality systems across a complex matrix organization.
Location: Hybrid position requiring reasonable commuting distance to sites in Houston, TX; Walkersville, MD; Portsmouth, NH; or Vacaville, CA. Up to 25% travel may be required.
Company
operates a global life sciences manufacturing network supporting the development and production of medicines.
What you will do
- Own supplier quality strategy, performance metrics, and compliance execution for assigned U.S. manufacturing sites and global supply networks.
- Lead supplier-related regulatory inspection readiness and serve as the quality liaison during FDA and health authority inspections.
- Direct deviation response, containment, escalation, and remediation for supply disruptions, material defects, and vendor non-conformances.
- Drive cross-functional supply chain quality projects, supplier improvement programs, CAPAs, and Tier 2 supplier performance reviews.
- Manage the U.S. account relationship with the global Integrated Facility Management service provider and coordinate with European counterparts.
- Implement quality risk management, supplier audits, trend analytics, electronic supplier lifecycle systems, audit trackers, and risk registers.
Requirements
- Typically 8+ years of experience in pharmaceutical, biotechnology, or medical device quality operations.
- Proven expertise in supply chain quality, supplier qualification, vendor monitoring, supplier performance improvement, and KPI management.
- Deep knowledge of cGMP, cGDP, Quality Risk Management, and supplier quality systems defended during FDA or health authority inspections.
- Bachelor’s degree in biochemistry, chemistry, pharmacy, microbiology, biotechnology, or a closely related scientific discipline.
- Strong leadership, communication, conflict-resolution, and stakeholder-management skills in a global matrix environment.
Nice to have
- Master’s degree in a relevant scientific discipline.
- Professional affiliation or membership with the PDA.
Culture & Benefits
- Agile career environment with a dynamic, inclusive, and ethical workplace.
- Strategic autonomy to shape supplier quality governance and risk-based evaluation methods.
- Medical, dental, and vision insurance, plus paid time off.
- Performance-oriented compensation programs and access to global benefits.
- Collaboration across a globally connected organization with more than 30 sites across five continents.
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