Senior Manager, Safety, Medical & Regulatory Quality

Job not on LinkedIn

🔥 0 minutes ago

🌽 Illinois – Remote

🌽 Illinois – Remote

💵 $124.5k - $236.5k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

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AbbVie

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

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

• Contribute to management of a global Safety, Regulatory Affairs, or Medical Affairs Quality Assurance team • Provide independent quality oversight of safety activities across AbbVie's R&D and non-R&D business functions and drug, device, and cosmetic portfolio • Collaborate with business partners and provide expert technical quality support and consultation • Support continuous compliance with global regulations, AbbVie policies, procedures, and regulatory preparedness • Support and execute a holistic quality assurance model for applicable GxP activities, including internal and vendor-performed activities • Develop innovative quality strategies and solutions and support responses to compliance issues, audits, and inspection findings • Evaluate compliance risks and propose mitigations • Support business process owners in integrating quality throughout process development • Participate in front- and back-room Regulatory Authority inspections involving safety, regulatory affairs, and medical affairs • Consult on worldwide safety, regulations, corporate policies, CAPA, and associated quality disciplines • Generate, analyze, and report compliance metrics and escalate issues for resolution • Contribute to global QA strategy systems, processes, and RDQA audit program • Drive change and efficiency through feedback and recommendations • Model AbbVie behaviors and leadership attributes

🎯 Requirements

• Bachelor's degree, preferably in Biology, Nursing, Pharmacy, or another science-based field • 5 years of pharmaceutical industry experience in pharmacovigilance, regulatory affairs, and/or quality assurance • 5 years of Quality Assurance experience • Strong analytical skills • Extensive knowledge of quality standards, worldwide regulatory requirements, and industry best practices relating to safety, regulatory affairs, or medical affairs • Ability to organize work logically, thoroughly, and succinctly • Ability to work with RDQA business partners and external partners • Flexibility to adapt to changing assignments and prioritize effectively with minimal supervision • Ability to work autonomously in a fast-paced, high-pressure, changing environment • Project management, interpersonal, communication, and influencing skills • Ability to work independently or as part of a team • Strong communication and interpersonal skills

🏖️ Benefits

• Paid time off, including vacation, holidays, and sick leave • Medical, dental, and vision insurance • 401(k) • Eligibility to participate in long-term incentive programs