Senior Manager, Clinical QA - Europe - Remote

Overview

The Senior Manager, Clinical QA will drive quality excellence across all stages of product discovery and development, ensuring compliance with regulatory standards and facilitating the submission of new therapies.

In Short

• Collaborate with RDQA functions impacting clinical research in Europe.
• Establish relationships with clinical development leaders to advance the AbbVie Quality System.
• Oversee quality and compliance in a regulated environment.
• Lead development of risk identification and mitigation strategies.
• Drive quality strategy in designated countries and region.
• Conduct audits to assess compliance with regulations.
• Provide oversight and support for local Health Authority inspections.
• Identify trends and root causes for quality issues.
• Support supplier visits, audits, and vendor qualifications.
• Maintain awareness of applicable regulations and develop quality standards.

Requirements

• Bachelor's degree in Biology, Nursing, Pharmacy, or related field.
• Experience in quality assurance, compliance, or regulatory affairs.
• Strong understanding of regulatory requirements and agency perspectives.
• Ability to respond to changing regulatory environments.
• Knowledge of quality systems and auditing standards.
• Excellent leadership and communication skills.
• Strong analytical and organizational skills.
• Ability to foster cross-functional collaboration.
• Fluency in additional languages is a plus.
• Willingness to travel up to 35% in the AREA.

Benefits

• Equal opportunity employer.
• Commitment to integrity and innovation.
• Opportunities for professional development.
• Supportive work environment.
• Community service involvement.