Senior Manager, Medical Device & Combination Product Quality Systems

Role Summary

The Senior Manager leads the sustainment, improvement, and globalization of the AbbVie quality management system for AbbVie medical devices and combination products. The role 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 business partners, demonstrating AbbVie quality management system compliance to external regulators, and leading continuous process improvement & globalization initiatives with cross-functional AbbVie team members.

Responsibilities

• Serves as the Deputy Person Responsible for Regulatory Compliance for 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 AbbVie 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 AbbVie quality management system in accordance with ISO 13485 and other country-specific device regulations under MDSAP.
• Leads root cause investigation and corrective action planning in response to external and internal audit observations, in collaboration with departmental process owners and subject matter experts.
• Maintains expertise in both current and emerging regulations and standards impacting AbbVie medical device and combination products.
• Performs regulatory compliance assessments to support the decision-making in critical business decisions, including Market Actions.
• Analyzes & interprets quality system performance metrics, presenting to Top Management as part of Management Reviews.
• Program manages initiatives intended to improve and globalize the AbbVie quality management system.

Qualifications

• Bachelor’s degree, preferably in engineering, physical science (e.g. Chemistry), life science (e.g. Microbiology or Biology) or pharmacy and a minimum of 8 years of industry experience in a GXP regulated environment, with a minimum 3 years in Quality Assurance Operations Management. A strong technical background is required because the scope of responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized technical fields.
• ISO 13485 Lead Auditor certification by a professional body is required. Additional accreditation by a professional body is desirable; examples include American Society of Quality (ASQ) Certified Manager of Quality & Operational Excellence (CMQ-OE), Six Sigma Black Belt Certification, or Project Management Professional (PMP) Certification.
• The role operates with a high degree of autonomy & accountability, making independent quality & compliance decisions timely and demonstrating the ability to manage multiple commitments while delivering on-time.
• The role also demonstrates an enterprise mindset, being able to influence without direct authority and apply past learnings to novel situations.
• Quality Assurance, Quality Control, Regulatory, Manufacturing, Laboratory or Validation background in a GXP regulated environment is required.
• Thorough, documented understanding/knowledge of GXP regulations.
• Regulatory inspection experience preferably with direct agency inspector interaction.
• Must have understanding and ability to anticipate and manage the sensitive nature of proprietary information.
• Strong project management skills are essential.
• Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.
• Key leadership competencies include cultural awareness, relationship building, ability to influence at all levels of the organization, teamwork building, sound judgement and the ability to make difficult decisions, often at short notice.