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Validation Manager
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit – an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Abbott Park, IL (Lake Bluff, IL) location in the Transfusion Medicine Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
As the Validation Manager, you’ll be responsible for leading the planning, implementing, and standardizing validation program activities. Develops and executes strategies that enable compliance with corporate and external regulations while driving consistent, efficient, and more timely practices. Responsible for the interpretation of requirements and development/maintenance of division level policies, processes, and procedures. The role provides subject matter expertise to the organization including education, technical support, issue resolution, integration of risk-based validation and project implementation strategy development within the site and across the division. Accountable for implementation of procedures that ensure compliance to corporate and divisional policy and Quality System Regulations. Potentially Division representative on related corporate initiatives and may influence externally through participation in industry groups.
What You’ll Work On
• Develop Validation Strategy for multi-million-dollar capital investments programs and gain cross-functional leadership alignment. Translates strategic needs of the division into executable long-range programs and projects. May deal with strategically important vendors or suppliers.
• Provide oversight, guidance, and subject matter expertise in the areas of Validation. Interact with peers and in other functions, and with direct staff, removes barriers impeding the progress of projects and programs., Validates Analyses: Reviews analyses conducted by direct reports to ensure that Quality objectives in the broader impact to other areas have been considered before action is taken on critical issues.
• Validation includes areas of Facility, Utility, Equipment, Software, Cleaning, Test Method, and Process.
• Act as system/process owner/SME for Abbott validation management solutions. Able to contribute functional skills and expertise broadly. Acts as a consultant at site and Division or in partnership with supplier for developing validation strategies for major projects.
• Lead or participate in the Validation Community of Practice teams in related areas to identify and promote best practices.
• Support audits in related areas and any associated resolution of observations.
• Supervise and develop QA professionals. Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources. Translates department goals into individual objectives.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews. Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Develops local strategy aligned with the business strategy and implements related tactical activities. Navigates challenges that emerge between project execution and policy requirement intent to a compliant outcome.
• Support the development, manufacture, and delivery of quality and compliant products on time, in full and cost effectively to meet the needs of the business and customers.
• Provides solutions to a wide range of difficult problems and elevates to management when appropriate. Ensures that solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives.
• Interacts effectively with employees, manager, and cross-functional peers. Represents team while on cross-functional project teams with other functional leaders.
• Directly influences project direction and scope.
• Demonstrates understanding of the standards and regulatory bodies that regulate our industry.
• Ensures adherence and maintains the effectiveness of the Quality System, including the Subsystems and Key processes that govern the area by promptly addressing non-compliance issues.
• Ensures evaluation of product safety and efficacy and elevation of risk-based issues.
• Recommends actions and develops responses to cope with various scenarios., Initiates Change: Shares and clarifies business strategy, identifies, and communicates a need for change, helps others understand the need for change, and drives change through the organization.
• Makes Decisions: Bases decisions on the overall good, rather than on benefit to a particular functional area, serves as a champion for specific projects and initiatives., Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions, and shares ideas freely.
• Contributes to the creation of the team’s mission, objectives, and strategies, accepts team decisions, and works toward their implementation.
Competencies
• Recognizes relative risks in processes and procedures and takes appropriate action.
• Follows and contributes to division level policies and procedures to promote consistency, establishes quality metrics for the unit, monitors and takes corrective action for processes and systems, builds partnerships with customers and suppliers in pursuit of quality improvement, allocates time for training and education programs for staff, assists in the translation of customer requirements into product requirements.,
• Utilizes good judgment and makes timely decisions which consider the facts and data at hand, champions specific projects, knows when to escalate to management.
• Follows through on promises and commitments and maintains confidence.
• Controls emotional reactions, copes with stress, is open to others’ ideas, demonstrates an understanding and appreciation of differences in others, treats others as individuals with unique skills, interests, and values, seeks to understand the goals and needs of others.
• Promotes productivity and morale by treating others with respect and dignity. Listens to different points of view, taking ownership and responsibility for own actions.
• Raises issues that block the achievement of individual and team performance, voices opinions and concerns without waiting to be asked, and attempts to establish areas of difference as well as areas of common interest.
• Influences others to support a course of action and to incorporate quality concepts in all activities, appropriately uses authority, influences activities without reliance on formal authority, and communicates unpopular decisions in a realistic but favorable light.
Required Qualifications
• Bachelor’s degree preferably in technical/scientific discipline e.g., Chemical, Physical or Biological Sciences, Pharmacy, Microbiology, Medical Technology, Engineering.
• A minimum of 8 years experience in Quality or Technical area, including two years of direct supervisory experience.
• Experience should include quality, technical product support and / or development, budgetary responsibility, and functioning in a matrix-managed environment.
Preferred Qualifications
• Master’s Degree preferred.
• Has 10 years related work experience, preferably in the healthcare industry.
• An excellent working knowledge of validation in a manufacturing operations production setting in a regulated industry. Including experience across multiple validation activities i.e., facility, utility, equipment, test method and process.
• Successful experience working on complex validation project/programs and delivery to schedule.
• Demonstrated two plus years leadership capabilities.
• Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $125,300.00 – $250,700.00. In specific locations, the pay range may vary from the range posted.
