Senior Manager, Medical Device & Combination Product Quality Systems

Role Summary

Senior Manager, Medical Device & Combination Product Quality Systems – lead sustainment, improvement, and globalization of the quality management system for AbbVie medical devices and combination products; serve as Deputy Person Responsible for Regulatory Compliance under EU MDR 2017/745; provide compliance SMEs support and drive continuous process improvement with cross-functional teams.

Responsibilities

• Serve as the Deputy Person Responsible for Regulatory Compliance for the assigned Device Legal Manufacturer under EU MDR 2017/745, supporting quality management supervision.
• Host External Audits in the US region, demonstrating QMS compliance to regulators for ISO 13485 and MDSAP-compliant audits.
• Conduct Internal Audits to assess QMS compliance with ISO 13485 and country-specific regulations under MDSAP.
• Lead root cause investigations and corrective action planning in collaboration with process owners and experts.
• Maintain expertise in current and emerging regulations affecting AbbVie medical devices and combination products.
• Perform regulatory compliance assessments to support critical business decisions, including Market Actions.
• Analyze and interpret quality system performance metrics; present findings to Top Management in Management Reviews.
• Program manage initiatives to improve and globalize the AbbVie QMS.

Qualifications

• Bachelor’s degree in engineering, physical science, life science, or pharmacy; minimum 8 years of GXP-regulated industry experience, with at least 3 years in Quality Assurance Operations Management.
• ISO 13485 Lead Auditor certification required; additional credentials (CMQ-OE, Six Sigma Black Belt, PMP) desirable.
• Autonomy and accountability in making independent quality and compliance decisions; ability to manage multiple commitments and deliver on time.
• Enterprise mindset with the ability to influence without direct authority; apply past learnings to new situations.
• Background in Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory, or Validation in a GXP environment.
• Thorough knowledge of GXP regulations; regulatory inspection experience with direct agency interaction preferred.
• Ability to manage sensitive proprietary information; strong project management skills.
• Excellent oral and written communication; ability to clearly present and justify quality requirements.
• Leadership competencies including cultural awareness, relationship-building, influence at all levels, teamwork, sound judgment, and decisive decision-making.

Skills

• Regulatory compliance expertise for medical devices and combination products
• Auditing (internal and external), CAPA, and quality metrics
• Cross-functional collaboration and program management
• Regulatory inspections and interaction with authorities
• Strong communication and leadership capabilities

Education

• Bachelor’s degree in engineering, physical science, life science, or pharmacy