Abbott Principal QA Professional, Quality Systems in Des Plaines, Illinois
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Abbott Molecular has a new opening for Principal Professional Quality Systems based in in Des Plaines, IL with significant presence in Manchester, NH. This role will be responsible for maintaining the effectiveness of the quality system for a Third Party Manufacturer (TPS) in the Design & Supplier Quality function. This role will work closely with key stakeholders within the TPM and AM Quality organizations to support internal auditing, external audit support, complaint handling, investigation and CAPA, document controls, training and management review support. Position will support and may lead initiatives to implement robust processes and drive process improvements.
Primary Function / Goals / Objectives: Conduct quality-related activities to deliver consistent; high quality documents; services; products and processes. Major Responsibilities: Responsible for implementing and maintaining the effectiveness of the quality system.
General - Develops local strategy which is aligned with the business strategy and implements related tactical activities. Translates strategic needs of the division into executable long-range programs and projects. Provide solutions to a wide range of difficult problems. Solutions are compliant; innovative; thorough; practical and consistent with organizational objectives. Leads projects with cross-functional broader scope. Represents team on cross-functional projects with other functional leaders. Directly influences project direction and scope. Interacts effectively with employees; manager; and cross-functional peers. Excels in effective and positive communications. Contributes functional skills and expertise broadly. Scope includes one or more QA functions with general knowledge of other related disciplines. Provides guidance and trains other Professionals and Technicians. May provide oversight to one or more QA professionals and/or contractors.
Quality System Compliance - Demonstrates complete understanding of the standards and regulatory bodies that regulate our industry. Ensures compliance to Division and Corporate policies and procedures. Implements and maintains effectiveness of the division Quality System; including the Subsystems and Key processes that govern the area by identifying compliance risks.
Risk Management - Defines the business results expected from risk management strategies and projects. Leads division in determining the changes; improvements; and investments needed to support the Risk Management process in the Quality System and business driven objectives. Makes independent decisions within broad parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system. Reviews and approves Risk management documentation.
Complaint Evaluation - Investigates complex complaints and carries out tasks with management guidance. Provides overall direction. Ensures compliant documentation in cross-functional areas of support.
Design Control / Documentation & Change Control - Demonstrates a strong working knowledge of the potential global impact of changes including safety and efficacy. Acts as Process Owner and represents the site as an SME or Process Community Member. Negotiates complex changes. Identifies key processes that may be impacted as a result of the change. Effectively reviews and discusses changes with key stakeholders.
Quality Engineering - Draws conclusions reflecting broad business and quality needs. Champions new initiatives and acts as the catalyst for change within and potentially across divisions. Negotiates complex quality decisions. Participates as SME in audits. Acts as a consultant at site and Division or in partnership with supplier for developing quality related strategies for major projects.
Education: Bachelor’s degree in Life Science; Engineering; or closely related discipline is required. Advanced Degree a plus.
Background: At least 8 years work experience in Quality or related filed experience; Less experience may be appropriate with advanced degree. Has experience in the health care industry. Has a history of completing successful cross-functional projects and driving positive compliance outcomes.
Accountability / Scope : Receives little detailed or general direction. Responsible for ensuring compliant documentation in cross-functional areas of support. Carries out tasks with management guidance; typically is responsible for decision making. Decisions have long term impact; aligned with the organization strategy
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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