Senior Manager, Medical Device & Combination Product Quality Systems

AbbVie • North Chicago, IL

86d

About The Position

The Senior Manager is responsible for leading the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. The role serves as Deputy Person Responsible for Regulatory Compliance for 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 other cross-functional AbbVie team members.

Requirements

• Bachelor's degree, preferably in engineering, physical science (e.g. Chemistry), life science (e.g. Microbiology or Biology) or pharmacy.
• A minimum of 8 years of industry experience in a GXP regulated environment, with a minimum of 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.
• 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.
• Strong project management skills are essential.
• Excellent oral and written communication skills required with the capability of clearly presenting and justifying quality requirements.

Nice To Haves

• 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.
• 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.

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.

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Short-term incentive programs
• Long-term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree