Senior Quality Partner
PharmaBiotechRegulatory AffairsQuality Assurancegmpemacroinform
Job description
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  www.abbvie.com . Follow @abbvie on  LinkedIn,   Facebook ,  Instagram ,  X  and  YouTube. The Senior Quality Partner is responsible for supporting quality assurance activities on the shop floor, ensuring compliance with Good Manufacturing Practices (GMP), regulatory requirements, and internal AbbVie standards. Acting as subject matter expert, this role collaborates with Production and other key stakeholders in ME&C,Quality, and Operations to resolve quality issues, support data collection and analysis, and drive continuous improvement initiatives. The Senior Quality Partner also supports successful regulatory inspections, fosters cross-functional partnerships, and upholds product quality to meet both customer and regulatory expectations. Responsibilities Serve as the Quality Assurance partner for one or more of the following areas – manufacturing, supply chain, engineering, quality control - overseeing critical stages of the Manufacturing and/or Operations processes to ensure compliance with all applicable GxP standards. Review and approve impact assessments for nonconformances, ensuring thorough evaluation and proper documentation. Act as QA reviewer and approver for Standard Operating Procedures (SOPs), compliance records, Nonconformance Reports (NCRs), CAPA plans, effectiveness checks, and other quality-related actions. Participate as a QA resource for site projects and compliance initiatives, providing quality input in project teams and representing QA in cross-functional settings. Collaborate closely with Production, Supply Chain, Engineering, Operations, and Quality Control teams to proactively identify risks, implement corrective actions, and prevent recurrence of issues. Oversee and monitor the timeliness of record completion, ensuring all documentation meets quality compliance and procedural requirements. Ensure projects are implemented appropriately and promptly, in alignment with current Good Manufacturing Practices (cGMP), ISO standards, and applicable regulations. Initiate and drive effective corrective and preventive actions and monitor their implementation to ensure sustained compliance and continuous improvement. Support investigations into quality incidents, driving root cause analysis and effective resolution. Participate in internal and external audits as required. Bachelor’s degree required in a scientific discipline or equivalent experience. 5+ years of combined experience in Manufacturing, QA, R&D in pharmaceutical, biologics, device or chemical industry Demonstrated knowledge of and experience with quality systems, corrective action and preventive action system, and other key tools for managing global quality performance in a regulated industry. Ability to work in a multinational, multicultural and highly matrixed environment. Strong communication Skills, both oral and written Proficient in computer skills and hands on experience with database management, spreadsheets, project management, presentations, word processing, flowcharting and/or any other similar type of software. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:  The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors  including  geographic location, and we may ultimately  pay more or less than the posted range. This range may be  modified in the future.  We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to  participate in our short-term incentive programs.   Note: No amount of pay is  considered to be wages or compensation until such amount isearned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable to a   particular employee  remains in the Company's sole and absolute discretion unless and until paid and may be  modified at the Company’s sole and absolutediscretion,  consistent with applicable law.  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.  US & Puerto Rico only - to learn more, visit  https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html
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