Senior Manager, Quality

Summary

Join AbbVie's team as Quality Manager, Global Lab Compliance and play a crucial role in ensuring the highest standards of quality and compliance across AbbVie operations.

Requirements

• Bachelor’s degree with 15+ years of Quality, PDS&T, and/or Regulatory experience
• Prior experience managing a QC laboratory or other technical/scientific group
• Strong knowledge of regulatory requirements and standards applicable to laboratory operations
• Experience developing and implementing compliance programs and conducting audits
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving skills
• Basic understanding and working knowledge of the physical and chemical characteristics of the products, including raw materials, used, or manufactured by AbbVie
• Familiar with use of statistical quality systems, electronic document management, and laboratory information management

Responsibilities

• Supports development and implementation of laboratory compliance programs by aligning policies and procedures with organizational goals and objectives
• Develops new regulatory policies, processes and SOPs and trains key personnel on them; evaluates regulatory risks of these policies, processes and procedures
• Develops and implements sustainable training programs to support compliance initiatives, ensuring that all personnel possess the knowledge and skills necessary to meet regulatory requirements and effectively utilize AI technologies
• Collaborates with cross functional teams to ensure training programs are relevant, engaging and updated regularly to reflect changes in compliance requirements and advancements in AI technologies
• Facilitates the alignment of site operations with global decisions by effectively influencing and engaging local teams
• Analyses key performance indicators (KPI) to assess the effectiveness of quality control programs and initiatives, identifying areas for improvement and implementing targeted solutions
• Effectively manages and executes strategic business opportunities to improve business processes
• Functions independently in high-level decision making for project related issues that have cross functional impact
• Employs logic and methods to independently and effectively problem solve. Probes multiple sources for answers. Rapidly understands, evaluates and identifies hidden problems and issues; develops solutions for more complex with little direction from management
• Makes good decisions based on a mixture of analysis experience and judgment
• Strong ability to multi-task and prioritize department goals while using resources effectively and efficiently

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)