Job Information
AbbVie Manager, Medical Device Quality Systems in Irvine, California
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Purpose:
Manager, Medical Device Quality Systems is responsible for supporting the sustainment, improvement, and globalization of the AbbVie quality management system in support of AbbVie medical devices and combination products. The role accomplishes this responsibility by providing regulatory subject matter expertise to internal business partners, demonstrating AbbVie quality management system compliance to external regulators, and performing program management of continuous process improvement & globalization initiatives with other cross-functional AbbVie team members.
Responsibilities:
Hosts External Audits, 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
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. 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.
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.
Additional Information
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
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