Senior Manager, Safety, Medical & Regulatory Quality

This is a fully remote position, open to applicants in Illinois.

📋 Description

• Assist in the management of a global Safety, Regulatory Affairs, or Medical Affairs Quality Assurance team.

• Offer independent quality oversight for safety-related activities across AbbVie's R&D and non-R&D business sectors, as well as its drug, device, and cosmetic portfolio.

• Work collaboratively with business partners to provide expert technical quality support and advice.

• Ensure ongoing compliance with global regulations, AbbVie policies, procedures, and readiness for regulatory assessments.

• Assist in the implementation of a comprehensive quality assurance model for relevant GxP activities, including those conducted internally and by vendors.

• Formulate innovative quality strategies and solutions while supporting responses to compliance challenges, audits, and inspection outcomes.

• Assess compliance risks and suggest mitigation strategies.

• Aid business process owners in embedding quality throughout the process development stages.

• Engage in both front- and back-room Regulatory Authority inspections concerning safety, regulatory affairs, and medical affairs.

• Provide consultancy on global safety, regulations, corporate policies, CAPA, and related quality disciplines.

• Generate, analyze, and report compliance metrics while escalating issues for resolution.

• Contribute to the global QA strategy, systems, processes, and the RDQA audit program.

• Propel change and efficiency through constructive feedback and recommendations.

• Exemplify AbbVie behaviors and leadership qualities.

⛳️ Requirements

• A Bachelor's degree, ideally in Biology, Nursing, Pharmacy, or another science-related field.

• A minimum of 5 years of experience in the pharmaceutical industry, specifically in pharmacovigilance, regulatory affairs, and/or quality assurance.

• At least 5 years of experience in Quality Assurance.

• Strong analytical capabilities.

• Comprehensive understanding of quality standards, global regulatory requirements, and industry best practices pertaining to safety, regulatory affairs, or medical affairs.

• Ability to organize work in a logical, thorough, and concise manner.

• Capability to collaborate with RDQA business partners and external stakeholders.

• Flexibility to adjust to changing assignments and effectively prioritize tasks with minimal supervision.

• Proficiency in working independently in a fast-paced, high-pressure, and dynamic environment.

• Skills in project management, interpersonal communication, and influence.

• Ability to work autonomously or as part of a collaborative team.

• Excellent communication and interpersonal skills.

🏝️ Benefits

• Paid time off, including vacation days, holidays, and sick leave.

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Opportunity to participate in long-term incentive programs.