Senior Quality Engineer - Combo Product External Quality

Join AbbVie as a Senior Quality Engineer focused on Combo Product External Quality. In this pivotal role, you will ensure the quality and compliance of our innovative combo products. Collaborate with cross-functional teams to uphold our commitment to excellence in healthcare solutions. Your expertise will be instrumental in driving quality initiatives and ma…

Join AbbVie as an Associate Director of Product Quality where you will play a critical role in ensuring the highest quality standards for our innovative pharmaceutical products. In this leadership position, you will oversee quality assurance processes, implement best practices, and lead a dedicated team to deliver exceptional quality outcomes.

Join AbbVie, a global biopharmaceutical company committed to developing innovative therapies, as the Manager of Medical Device External Quality. In this pivotal role, you will lead initiatives to ensure the highest quality standards for our external medical device manufacturing partners.Your responsibilities will include overseeing quality assurance processes, conducting audits, and collaborating with cross-functional teams to ensure compliance with regulatory requirements and internal policies.

As a Senior Quality Engineer, you will play a crucial role in representing the Quality Assurance (QA) function on interdisciplinary teams focused on the development of combination products and medical devices. Your primary responsibility will be to ensure that all aspects of product development, manufacturing, testing, and procurement, as well as the resulting data, comply with global Combination Product and Medical Device Regulations.Key Responsibilities:Execute QA activities associated with Combination Product and Medical Device Development to uphold compliance with corporate policies and procedures.Conduct design control and risk management activities in alignment with AbbVie's Quality System.Collaborate with Quality and Operations teams to guarantee adherence to design control documentation and design change control requirements.Manage third-party supplier activities by reviewing their design control processes.Assist in the preparation of regulatory submission documents.Identify and address gaps or opportunities for improvement within the Design History File and Risk Management documentation.Proactively lead projects and process improvement initiatives, anticipating and resolving quality issues.Monitor process effectiveness and quality of project outputs, proposing and implementing improvements.Utilize your knowledge of global regulations and standards to guide compliance efforts.Lead and participate in regulatory agency audits and internal audits.Conduct thorough investigations for Incident Reports (IRRs), Non-Conformance Reports (NCRs), and other observations, ensuring accurate documentation.Engage in departmental Change Control activities, performing impact assessments on design changes.Review and approve design changes pertinent to late-stage development projects.Support regulatory authority interactions, including Notified Body audits.Draft and revise quality procedures, forms, and documentation as required.Collaborate with cross-functional teams to foster continuous improvement and drive change.

We are seeking a dedicated and experienced Aseptic Product Quality Manager to join our team at AbbVie. In this pivotal role, you will be responsible for ensuring the quality and compliance of our aseptic products throughout the manufacturing process. You will lead a team of quality assurance professionals, collaborate cross-functionally, and drive initiatives to uphold our commitment to excellence in product quality.

Join AbbVie as a Senior Manager of Technology Quality, where you will lead initiatives to ensure the highest quality standards in our technology operations. You will manage a talented team, drive continuous improvement processes, and collaborate with cross-functional teams to enhance our product offerings. Your expert knowledge of quality management systems will be essential in guiding the team to achieve compliance and operational excellence.

Join AbbVie, a global biopharmaceutical company, as a Quality Systems Engineer within our QC Laboratories. In this role, you will play a critical part in ensuring the quality and compliance of our products by overseeing quality systems and processes. You will collaborate with cross-functional teams to identify and resolve quality issues, implement best practices, and drive continuous improvement initiatives.

Join our dynamic team at AbbVie as a Principal Engineer specializing in Quality Assurance and DevOps. In this integral role, you will lead the development and implementation of robust testing frameworks and automation strategies to ensure the highest quality of our software products. Your expertise will guide our engineering practices, enabling us to deliver innovative solutions that meet the evolving needs of our customers.

AbbVie Inc. is seeking a Senior Manager of Clinical Quality Assurance for its North Chicago location. This position takes responsibility for leading quality assurance activities across clinical trials, with a focus on maintaining compliance with regulatory requirements and upholding high standards in clinical quality management. Role overview The Senior Manager will oversee quality assurance processes related to clinical studies. The role involves close collaboration with teams from different functions to strengthen the quality of clinical research and implement initiatives that support both patient safety and the integrity of study data. Key responsibilities Lead and monitor quality assurance procedures for clinical trials Ensure all processes align with current regulatory standards Work with cross-functional teams to improve the quality of clinical studies Support efforts that promote patient safety and reliable data collection

We are seeking a highly skilled Quality Systems Engineer in our QC Labs to independently identify, develop, and enhance innovative data, software, and technology solutions that meet critical business needs. In this role, you will collaborate closely with Quality Assurance Lab Business Owners and the broader Business Technology Solutions (BTS) team to optimize existing methods and processes. Utilize literature and available public information to effectively complete assignments. You will demonstrate expertise in a diverse range of techniques for information technology engineering, including software development, data warehousing, statistics, machine learning, and technology infrastructure.Key Responsibilities:Design and develop technology solutions to address scientific and business inquiries, showcasing proficiency in programming languages, data integration, data warehousing, and data visualization.Comprehend project objectives and adapt strategies as necessary. Proactively escalate issues to ensure project success, maintaining clear communication with stakeholders.Continuously learn and master new technologies and methods, serving as a resource or mentor to team members.Effectively organize and present project objectives and progress, contributing to technical publications and presentations.Obtain vendor estimates and quotes to inform overall project time and cost assessments.Produce and maintain essential technical documentation associated with deliverables.Collaborate cross-functionally with IT shared services, manufacturing representatives, and QA Labs stakeholders.Define data, reporting, and AI strategies for AbbVie QC Labs, outlining value-based roadmaps to enhance business insights and operational efficiency.Analyze and resolve technical issues using analytical problem-solving methods and tools.

Are you passionate about ensuring top-notch quality standards in technology solutions? Join our team as a Quality Assurance Specialist! In this role, you will be responsible for developing and executing test plans, identifying defects, and collaborating closely with cross-functional teams to guarantee that our products meet the highest quality benchmarks. You will play a vital role in driving continuous improvement and delivering exceptional user experiences.

AbbVie is seeking a passionate and experienced Director of Clinical Quality Assurance to lead our quality assurance initiatives in clinical trials. This role is pivotal in ensuring compliance with regulatory requirements and enhancing the quality of our clinical research activities.

Join AbbVie as a Senior External Cost Analyst where you will play a critical role in managing and optimizing external costs. You will analyze financial data, prepare reports, and provide insights that drive strategic decision-making. This is an exciting opportunity to contribute to our mission of advancing health and wellness around the globe.

The Distribution Quality Assurance Section Manager plays a crucial role in ensuring the highest standards of quality within our distribution operations. You will lead a dedicated team responsible for maintaining compliance with regulatory requirements and internal policies, fostering a culture of continuous improvement, and enhancing overall efficiency.

We are seeking a dynamic and experienced Manager of Business HR to lead our Quality division at AbbVie. In this role, you will be responsible for aligning human resources strategies with business goals, fostering a high-performance culture, and driving initiatives that enhance employee engagement and organizational effectiveness.

Join AbbVie as the Director of External Manufacturing, where you will play a pivotal role in overseeing and enhancing our manufacturing operations. In this leadership position, you will lead strategic initiatives to optimize our external manufacturing partnerships, ensuring the highest quality and efficiency in production.Your expertise will drive the development and implementation of best practices across our supply chain, while fostering collaborative relationships with internal teams and external partners. This is an exceptional opportunity to make a significant impact in a leading global biopharmaceutical company.

AbbVie is seeking an experienced and dynamic professional to join our team as the Director of OneHUB External Hubs. In this strategic leadership role, you will oversee the development and management of our external hub network, ensuring optimal operations and alignment with company goals.Your mission will involve collaborating with cross-functional teams, driving innovation, and enhancing customer engagement through our external hubs. This position offers a unique opportunity to make a significant impact on our business strategy and operations.

Join AbbVie as the Manager of External Supply, where you will play a pivotal role in enhancing our supply chain efficiency. You will lead initiatives to optimize our external supply operations, ensuring seamless collaboration with suppliers and internal teams.

Purpose:Lead a team of manufacturing professionals overseeing Third Party Manufacturing (TPM) contracts for small molecule products. Ensure that high-quality products are produced in compliance with local and international regulations, and delivered according to established forecasts, schedules, and budgetary plans.Responsibilities:Manage a team of AbbVie TPM Account Managers to negotiate Manufacturing Service Agreements and amendments, ensuring compliance with contractual terms while implementing effective planning and material procurement strategies to support TPMs.Oversee global logistics to facilitate all phases of the manufacturing agreement in alignment with Purchasing and Supplier quality expectations.Ensure timely communication with TPMs regarding all aspects of product agreements, including forecasts, manufacturing, and delivery schedules.Lead the development of the Financial Operating Plan, updates, LRP, and standard processes, ensuring financial targets are met.Monitor manufacturing performance, applying appropriate metrics and ensuring work processes and standards align with AbbVie's quality expectations.Coordinate with internal AbbVie functional partners to ensure TPMs have the required quality systems and documentation to comply with regulatory standards, overseeing inspection responses and commitments.Foster a culture of continuous performance improvement across TPMs and guide Account Managers in identifying opportunities to enhance efficiency and effectiveness.Coach managers within the organization, establishing clear expectations regarding responsibilities, goals, and behaviors while exemplifying exceptional AbbVie performance and talent management practices.Facilitate routine management reviews and maintain ongoing communication with internal and TPM stakeholders about TPM performance against expectations, highlighting issues and actions for improvement.Represent the Manufacturing department in interactions with internal Brand Teams regarding all facets of the manufacturing process with TPMs, while developing and managing staff through hiring, performance management, talent development, and setting clear expectations.

Join AbbVie as the Director of External Manufacturing - Aseptic, where you will play a pivotal role in managing our aseptic manufacturing operations. In this leadership position, you will oversee the strategic partnership with external manufacturers, ensuring compliance with industry standards and optimizing production efficiency. This role requires a deep understanding of aseptic processes, strong leadership skills, and the ability to drive continuous improvement initiatives.