Senior Director, Operational Excellence

🕒 vor 2 Tagen

🇺🇸 Vereinigte Staaten – Remote

💵 $199.782 - $270.293 / Jahr

⏰ Vollzeit

🟠 Senior

⚙️ Operations

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Amgen

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10.000+ Mitarbeiter

Gegründet 1980

🧬 Biotechnologie

💊 Pharmazie

🔬 Wissenschaft

💰 €28.500.000.000 Post-IPO Debt im 2022-12

Biotechnology • Pharmaceuticals • Science

Amgen ist ein weltweit führendes Unternehmen in der Biotechnologie, das sich auf die Entwicklung und Vermarktung innovativer Arzneimittel aus lebenden Zellen konzentriert. Das Unternehmen hat zum Ziel, schwere Krankheiten zu behandeln, wobei oft Krankheiten im Fokus stehen, für die es nur begrenzte therapeutische Möglichkeiten gibt. Amgen legt großen Wert auf wissenschaftliche Innovation und ist der ethischen Forschung, der Patientensicherheit und der ökologischen Nachhaltigkeit verpflichtet. Es ist aktiv in klinischen Studien engagiert und bekannt für seine Beiträge in den Bereichen Krebsbehandlung und Adipositas-Management unter anderem.

Beschreibung

• Lead the strategy, governance, transformation, and execution of continuous improvement initiatives across the Research & Development (R&D) Quality organization • Drive scalable, efficient, compliant, and data-driven processes that enhance quality oversight across GCP, GLP, GVP and research functions • Lead governance frameworks, strategic project management, and Quality support for business development activities • Develop and execute a multi-year Operational Excellence roadmap aligned to R&D Quality strategy and enterprise priorities • Establish and lead governance processes for the R&D Quality • Drive R&D GXP quality governance models to ensure adequate quality performance and escalation from L2 through L0 • Support Global Quality efforts, representing R&D quality, on quality governance as needed • Drive annual goal setting, portfolio prioritization, budget tracking, and business performance reviews • Identify and lead/monitor cross-functional improvement initiatives across audits/inspections, quality systems, CAPA, supplier quality, and oversight models • Establish project management standards, tools, and governance for strategic Quality initiatives • Lead a portfolio of enterprise and functional projects ensuring scope, timelines, resources, risks, and deliverables are managed • Represent R&D Quality in acquisition assessments, licensing opportunities, and strategic partnerships • Lead Quality due diligence and execute post-close integration plans for acquired assets • In partnership with Global Development, establish KPIs to measure quality performance, efficiency, risk, and project delivery • Build operational excellence and project management capability through coaching, training, and mentoring • Act as a trusted advisor to senior leaders, bringing insights and thought leadership on operational performance • Demonstrate foresight in identifying emerging challenges and opportunities (“looking around corners”).

🎯 Anforderungen

• Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR Master’s degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR Bachelor’s degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry • at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources • Strong knowledge of GxP regulations including GCP, GLP, PV, and quality system management • Demonstrated success leading enterprise transformation, governance and complex integration programs • Strong executive presence with ability to influence senior stakeholders • Advanced degree (MBA, MS in Operations/Engineering, or similar) • Certification in Lean Six Sigma (Black Belt or Master Black Belt) • Demonstrated expertise in designing and implementing KPIs and performance management frameworks • Strong financial and business acumen; capable of building business cases and measuring ROI • High EQ, exceptional communication skills, and experience consulting with senior stakeholders • Strategic mindset with operational execution capabilities—able to align vision with delivery • Experience integrating data science, AI, or digital tools in operational settings. • Comfortable with ambiguity and rapid change; thrives in a matrixed, global organization.

🏖️ Vorteile

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions • group medical, dental and vision coverage • life and disability insurance • flexible spending accounts • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan • Stock-based long-term incentives • Award-winning time-off plans • Flexible work models where possible.