Manager, Quality Assurance – Regulatory Affairs

🕒 Maio 7

🏈 Alabama, California, +14 estados a mais – Remoto

🏈 Alabama – Remote 🏄 California – Remote ⛰️ Colorado – Remote 🏛️ District of Columbia – Remote 🐊 Florida – Remote 🌽 Illinois – Remote 🌪️ Kansas – Remote 🏖️ New Jersey – Remote 🌲 North Carolina – Remote 🏈 Ohio – Remote 🌲 Oregon – Remote 🍂 Massachusetts – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote 🤠 Texas – Remote ⚔️ Virginia – Remote

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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PerkinElmer

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 1938

🔬 Ciência

💊 Farmacêutico

⚕️ Seguro de Saúde

Science • Pharmaceuticals • Healthcare Insurance

A PerkinElmer é líder global no fornecimento de soluções analíticas e de testes para uma ampla gama de setores, incluindo o farmacêutico, a segurança de alimentos, a análise ambiental e os testes industriais. A empresa oferece equipamentos avançados e consumíveis, incluindo espectrômetros de massa, instrumentos de cromatografia e sistemas de espectroscopia. Com mais de 85 anos de experiência, a PerkinElmer é comprometida com a inovação e dedicada a fazer parceria com laboratórios em todo o mundo para impulsionar a descoberta científica e garantir a qualidade e a segurança de produtos. Seus serviços atendem setores como saúde, alimentos e bebidas, testes ambientais e aplicações industriais, ajudando os clientes a atender às exigências de conformidade e aos padrões de qualidade.

Descrição

• Serve as a delivery leader on tactical quality and regulatory engagements, including but not limited to: Quality Management System (QMS) remediation, Investigation activities, Submission support, Supplier Quality Audits, New Product Introduction QA/RA support. • Ensure delivery excellence, regulatory rigor, and strong client outcomes across all engagements. • Maintain high billable utilization consistent with consulting expectations. • Travel as required to support client projects and audits. • Identify opportunities to expand existing engagements into broader or deeper quality and regulatory programs. • Actively contribute to PF’s reputation as a leader in quality and regulatory consulting.

🎯 Requisitos

• Bachelor's degree in scientific, regulatory, engineering, or related discipline preferred. • 10 years (Manager) -17 years (Sr. Mgr) of experience in life sciences quality, compliance, or regulatory roles, including consulting and/or owner-side leadership. • Demonstrated success delivering and advising on complex GxP, regulatory, and quality system initiatives. • Strong working knowledge of global regulatory frameworks (FDA, EMA, MHRA, ICH, WHO). • Proven ability to support sales and business development in a consulting environment. • Executive presence with strong written and verbal communication skills. • Willingness and ability to travel regularly in support of project delivery and client needs. • Strong communicator and influencer across multiple disciplines. • Is able to easily achieve agreement and collaborative resolution to project issues. • Structured thinker with advanced troubleshooting and problem-solving skills. • Skilled at managing multiple priorities in a high pressure, regulated environment. • Ability to manage scope and track project changes • Demonstrated leadership and mentorship abilities. • Applicants must be authorized to work in the United States on a full-time basis.

🏖️ Benefícios

• PerkinElmer is committed to creating a diverse environment • Equal opportunity employer