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Purpose :
Primarily responsible for carrying out comprehensive quality system audits of third-party service providers and manufacturers for compliance with applicable global regulatory requirements. Responsible for providing quality
consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of new product development programs worldwide
Responsibilities :
Carry out job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies.
Independently plan and conduct external supplier audits assessing compliance of systems, facilities, and processes per applicable regulations and AbbVie specifications.
Provides feedback in the form of audit observations and reviews corrective actions to determine if commitments have been properly implemented, are proven to be effective, and are being maintained.
Assist in maintaining approved supplier list, global audit schedule and participate in supplier management processes (e.g. Management Review, Supplier Change Notifications, etc.).
Provide guidance and training on GxP regulations and guidelines to audit team members and internal business partners.
Assist on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers.
Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
Expected to elevate any issues to management, as necessary, in meeting these responsibilities.
Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight.
Participates in strategic initiatives to improve compliance to regulatory requirements and standards.
Collaborate with AbbVie Operations in coordinating and conduct of joint audits.
Ensures audits are conducted according to the annual audit schedule.
This is an experienced level compliance position that reports to the Director RDQA External Partners Quality Audit or designee. This individual is expected to identify and resolve problems through effective interpersonal skills. The incumbent will work effectively independently or as a team, mentor others, and also be an effective cross-functional team leader. Must be able to effectively communicate and influence others outside of the company as well as internal stakeholders across functional and technical areas.
Bachelor’s degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering).
Demonstrated strong leadership competencies, proficient level of technical capabilities, and independence. Proven track record utilizing core & technical competencies.
8+ years’ total experience, including 3+ years in compliance or auditing role.
Sufficient exposure to pharmaceutical, medical device, biologics and combination products, cosmetics, eye care or aesthetics related industries and thorough understanding of international GMP and Device regulatory standards (e.g. US FDA, EU, MDR/IVDR, etc.).
Quality Assurance auditing experience (preferred) Pharmaceutical/Device Manufacturing experience (preferred) An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA))
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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About AbbVie
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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie , please visit us at . Follow @abbvie on LinkedIn,Facebook, Instagram, X and YouTube.
