Associate Director, Global Quality and Compliance Excellence

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🔥 0 minutes ago

🌲 Oregon – Remote

🌲 Oregon – Remote

💵 $141.5k - $268.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• Leads preparedness for regulatory inspections ensuring compliance with global standards • Conducts mock audits and coaches site leadership for successful audit outcomes • Develops audit and inspection readiness plans • Collaborates with AbbVie teams for compliance and quality deliverables • Provides guidance on quality concerns ensuring new product launches meet requirements

🎯 Requirements

• Bachelor’s Degree in relevant Life Science or other technical area required • Graduate degree desired • 10+ years of experience in Quality Assurance, Regulatory, Operations, or Technical Support in a pharmaceutical or medical device setting required • Experience working in a regulatory agency preferred; direct interaction with regulatory inspectors required • 6+ years of direct Plant leadership in a pharmaceutical setting preferred • Experience working with third party external manufacturers preferred • Comprehensive understanding of biological and/or pharmaceutical technologies (sterile, biological, devices, etc.) • Strong analytical problem-solving skills

🏖️ Benefits

• paid time off (vacation, holidays, sick) • medical/dental/vision insurance • 401(k) to eligible employees • participate in long-term incentive programs