Senior Associate, Product Development Quality Assurance-Hybrid, Chicago

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. This role is primarily responsible for supporting AbbVie’s pipeline, by supporting batch disposition activities and ensuring high-quality clinical supplies that are compliant with global regulatory requirements and standards are delivered to patients. This is achieved by effectively partnering with the business, ensuring risks are mitigated appropriately and supporting efficient review of clinical supply batches to support continued uninterrupted access to clinical supplies. The successful candidate will be able to manage multiple tasks and adjust priorities based on supply needs. This position requires the ability to positively interact with multiple functional areas quickly and effectively resolve batch record documentation related issues independently, ensuring schedules are maintained and material is readily available. Responsibilities: Review and approve batch records and release batches or analytical records. Write/ review/ approve processes/procedures and related documents. Lead/assist in the preparation and management of audits conducted by regulatory agencies, customers, and R&D GxP Compliance. Provide quality approvals in the materials management system as defined by procedures. Write, review and/or approve exception documents and product complaints (as applicable), corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements. Review/approve clinical documentation and specifications, as applicable. Actively lead/participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues. Generate, analyze, and report quality metrics to management. Lead/participate with support groups in developing/prioritizing QA activity timelines. Actively monitor the effectiveness of processes and quality of project work with management and propose and execute quality/process improvements. Provide quality oversight on the manufacturing floor, as needed. Bachelor’s degree, typically in life sciences (biology, chemistry, or engineering), and/or equivalent experience. 4+ years of industry experience in Quality Assurance, production, or testing of active pharmaceutical ingredients, drug products, drug development, or another healthcare-related field; less experience may be considered with an advanced degree. Broad understanding of pharmaceutical manufacturing processes (chemical and biological), analytical sciences, and worldwide GMP requirements (D, EU, US) is preferred. Experience coordinating and planning complex activities. Proven organizational skills. Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities. Effective oral and written communication skills to clearly communicate the quality position and the actions necessary to resolve issues. Ability to identify and resolve complex problems through effective use of technical and interpersonal skills. 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 role at  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors  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 is earned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable 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 absolute discretion,  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