Senior Manager, Medical Device & Combination Product Quality Systems

Role Summary

Senior Manager responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. Serves as Deputy Person Responsible for Regulatory Compliance for the assigned Device Legal Manufacturer under EU MDR 2017/745, providing compliance subject matter expertise to internal partners, ensuring QMS compliance to external regulators, and leading continuous process improvement and globalization initiatives with cross-functional teams.

Responsibilities

• Serves as the Deputy Person Responsible for Regulatory Compliance for the assigned Device Legal Manufacturer under EU MDR 2017/745, supporting quality management supervision under the direction of the Management Representative.
• Hosts External Audits primarily in the US region, demonstrating quality management system compliance to external regulators for ISO 13485 and other country-specific device audits under MDSAP.
• Conducts Internal Audits to assess the compliance of the quality management system with ISO 13485 and other country-specific device regulations under MDSAP.
• Leads root cause investigation and corrective action planning in response to audit observations, in collaboration with departmental process owners and subject matter experts.
• Maintains expertise in current and emerging regulations and standards impacting medical devices and combination products.
• Performs regulatory compliance assessments to support decision-making in critical business decisions, including Market Actions.
• Analyzes and interprets quality system performance metrics, presenting to Top Management as part of Management Reviews.
• Program manages initiatives to improve and globalize the quality management system.

Qualifications

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

Skills

• Regulatory compliance and regulatory affairs
• Quality management systems (ISO 13485, MDSAP)
• Internal and external audit leadership
• Root cause analysis and corrective action
• GXP regulations knowledge
• Regulatory inspections and interaction
• Cross-functional collaboration and influence
• Quality metrics analysis and management review presentations
• Project management

Education

• Bachelor‚Äôs degree as specified in Qualifications

Additional Requirements

• Travel expectations not specified