Validation Manager - North Chicago, United States - Abbott Laboratories company

Description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Validation Manager

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve peoples health. Were 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. Youll 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 bachelors 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 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, youll help develop and coordinate the validation schedule working with multiple departments to ensure compliance to the schedule and on time completion of projects.

What Youll Work On

• 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.
• Provides solutions to a wide range of difficult problems.
• Ensures that solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives.
• Leads projects with cross-functional or broader scope.
• Interacts effectively with employees, manager, and cross-functional peers.
• Represent own team while on cross-functional project teams with other functional leaders.
• 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 and KPIs.
• 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.
• Communicates confidently and effectively with management, peers, and key stakeholders.
• Provides guidance and trains other Professionals and Technicians.
• Able to contribute functional skills and expertise broadly.
• Directly influences project direction and scope.
• Scope includes one or more QA functions, with general knowledge of other related disciplines.
• Provides guidance and trains other Professionals and Technicians.
• Demonstrates complete understanding of the standards and regulatory bodies that regulate our industry.
• Ensures compliance to site level policies and procedures and demonstrates a solid understanding of Division and Corporate policies and procedures by promptly addressing noncompliance issues within Division and Corporation as appropriate.
• 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.
• Defines the business results expected from risk management strategies and projects.
• Makes independent decisions within defined parameters while assuring that these decisions are compliant with site level policies and procedures and are aligned with the appropriate quality system.
• Provides solutions to a wide range of problems in which solutions are compliant, innovative, thorough, practical, and consistent with organizational objectives.
• Ensures compliant documentation in area of responsibility.
• Represents the site as an SME or Process Community member.
• Applies solid understanding of quality system elements from product inception through launch.
• While recognizing project interdependencies and with minimal oversight, leads complex quality discussions across various departments including, as needed, external suppliers.
• Acts as site SME in audits for all aspects of validation. Acts as a consultant at site and Division or in partnership with supplier for developing validation strategies for major projects.

Required Qualifications

• Bachelors Degree in Scientific or technical discipline, OR an equivalent combination of education and work experience
• Minimum 5-7 years of experience in function or related field.
• 2 years of direct supervisor experience.

Preferred Qualifications

• Masters degree preferred with 8 years work experience in Quality or related filed experience.
• Has experience in the health care industry.
• Has a history of completing successful cross-functional projects and driving positive compliance outcomes.
• An excellent working knowledge of validation 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 leadership capabilities.
• Must have demonstrated solid knowledge and experience in discipline. Considered a Subject Matter Expert.
• Demonstrated ability to lead cross-functional projects.
• Flexibility, strong critical thinking skills, excellent written and oral communication skills, solid organizational ability, negotiations skills with ability to drive cross functional teams.
• Emerging leader that demonstrates strong leadership competencies.

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:

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.

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The base pay for this position is $109,300.00 $218, In specific locations, the pay range may vary from the range posted.