Manager, Quality and Validation (software)
Abbott
Manager, Quality and Validation (software)
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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.
Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Lake Forest, IL location in the Transfusion Medicine Division. We’re empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott’s diagnostics instruments, providing lab results for millions of people.
As the Manager, Quality and Validation (software), you’ll have the chance to lead the team of Quality supervisors/engineers/technicians to support Manufacturing, Supplier Development, New Product Development, and Quality Systems. Directs projects to ensure the manufacture of high-quality product and to facilitate compliance with regulatory requirements.
What You’ll Work On
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.
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.
Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
Monitors compliance with company policies and procedures (e.g., compliance with FDA, BSI, EEO regulations etc.).
Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
Translates department goals into individual objectives and KRAs.
Identifies, develops, and implements processes to improve department performance.
Monitors departmental activities and records to ensure compliance independent action through critical decision making.
Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
May also direct work assignments for quality control auditors.
Directs Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
Promotes the attainment of group goals by selecting, motivating, and training capable staff.
Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.
Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability.
Carries out operations within an established budget.
Assignments are expressed in the form of tasks and objectives.
Generally, makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management.
Consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.
Required Qualifications
Bachelor's degree and 9+ years of related work experience or an equivalent combination of education and work experience.
Preferred Qualifications
Advanced degree preferred.
Supervisors experience with leading a team toward departmental goals; monitors costs of projects and resources within a department or unit; monitors external environment in area of technical or professional responsibility. Will perform this job in a quality system environment.
Lead and oversee Non-Product Software Validation end-to-end activities in compliance with 21 CFR Part 11 and ensure robust data integrity practices.
Manage and develop local and global teams, fostering a positive and high-performing team culture.
Collaborate effectively with cross-functional teams (CFTs) across multiple global locations to drive alignment and validation project success.
Provide strategic and operational support during regulatory audits (e.g., FDA, Notified Bodies), including front-room representation and back-room coordination.
Oversee the management of non-conformances and Corrective and Preventive Actions (CAPAs) to ensure timely resolution and compliance.
Design, implement, and continuously improve processes and quality systems to enhance efficiency and compliance across the organization.
Review and update processes based on regulatory changes to maintain compliance and ensure best practices.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.
The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.