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Sr. Manager, Quality Assurance

4 months ago

Lake Forest, United States Abbott Laboratories Full time

Abbott Rapid Diagnostics is part of Abbottâs Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

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. Youâll 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 bachelorâs 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

The position of Senior Manager, Quality Assurance works out of our Lake Forest, IL location within our Toxicology business unit.  This is a people manager role and will be responsible for establishing operating policies and procedures that affect departments and subordinate sections and work units and Interpreting companywide policies and procedures. They will develops budgets, schedules and performance standards. Assignments are objective oriented. Work is reviewed in terms of meeting the organization's objectives and timelines and will eventually manage a team.

What You'll Work on

  • Provide direction and leadership for product quality and compliance.

  • Interacts frequently with internal and external management and senior-level representatives concerning projects, operational decisions, scheduling requirements and or contractual clarifications.

  • Leads briefings and technical meetings for internal and external representatives.

  • Responsible for managing multiple quality system elements/functions as defined in the site/BU Quality Manual.

  • Decision making that has an extended impact on work processes and outcomes, that could cause substantial expenditure of additional time, human resources, and funds; and jeopardize future business activity.

  • Develop, implement and improve quality processes and procedures, automated systems and reporting systems.

  • Implements the quality plan in accordance with the quality objectives/goals and maintains the effectiveness of the quality system.

  • Serves as representative for external regulatory inspections and audits.

  • Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, DOT regulations, Clinical Laboratory regulations, etc.

  • Responsible for ensuring that functional areas of responsibility have adequate training programs for adhering to all safety requirements and business EHS goals.

  • Develop quality goals based on the business strategies, collaborates with other business units on common goals and drives for results.

  • Leads complex process improvement teams and/or initiatives.

  • Establishes and implements necessary communication strategy for the improvement and awareness of the quality issues.

  • Responsible for the development and management of staff.

  • Ensures that product acceptance activities are handles in a manner that complies with all pertinent regulatory requirements. Reports on the performance of the quality system.

  • May be responsible for global QA function within one discipline or multiple disciplines at one site.

  • Balance complex resource needs across QA functions.

  • Responsible for department financials and for managing cost improvements.

  • Identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.

  • Define and implement superior Process Control & Monitoring systems for KPIV and KPOV throughout the product lines â Critical Parameter Management.

  • Oversee the Nonconformance and Real-time data management portions of the Quality System.

  • Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.

  • Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.

  • Support all Business Unit initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.  Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors, as applicable.

  • Assures that the Quality continuous improvement processes (NCâs and CAPAâs) meets TOX metric expectations for key metrics and assure that when metrics are not achieved that clear plans for improvements are implemented and achieved.

  • Will be a part of the team that interfaces with external audits and may serve as the subject matter expert frequently communicating with external legal or regulatory bodies.

  • Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.

  • Translates department goals into individual objectives and KRAs.

  • Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.

  • 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.

  • 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.

  • Provides QMS support by defining work assignments directed to address nonconformances and implement process improvements utilizing Quality System tools.

  • Monitors departmental activities and records to ensure compliance independent action through critical decision making.

  • 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.

  • Manages performance of staff towards department and Company goals, including feedback on performance, appraisals, recommendations for merit increases or necessary disciplinary actions, communication to employees on performance, etc.

  • Demonstrates commitment to the development, implementation and effectiveness of Abbott Quality Management System per ISO, FDA, and other regulatory agencies.

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job; has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.

Required Qualifications

  • BS/BA degree in a science related or technical field  or other field with equivalent combination of work experience.

  • Minimum 10 years progressively work experience in medical device or regulated industries.  Roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired. 

  • experience.

  • Minimum 6 yearsâ of direct supervisor experience.

  • Working knowledge of Quality Assurance in a medical device or in-vitro diagnostic business.

  • Knowledge of FDA Quality System Regulations and/or ISO 13485 and other relevant clinical/regulatory requirements.

  • Ability to travel approximately 10%, including internationally.

Preferred Qualifications

  • Six Sigma black belt certification.

  • Experience working in a regulated environment required: GMPs, GLP's and GCP's.

  • Strong management skills with proven leadership and team building skills.

  • Demonstrated and impactful experience in process improvement , Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).

  • Ability to work in a highly matrixed and geographically diverse business environment.

  • Assesses issues thoroughly and solves complex problems; removes roadblocks for the team.

  • Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies.

  • Holds others accountable by focusing on the right metrics, tracking results and creating transparent reviews.

  • Excellent organization skills â must be able to manage a large number of simultaneous projects. 

  • Attention to detail â must have precision in work completed, especially as it relates to understanding and documenting complex quality issues.

  • Excellent writing skills â must be able to summarize complex issues in a clear, succinct and accurate manner. Must be able to write in a manner that effectively conveys complex issues to the reader.

  • Strong communication, problem solving and motivational skills with ability to effectively communicate at multiple levels in the organization.

  • Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

* 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.

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.



The base pay for this position is $125,300.00 â $250,700.00. In specific locations, the pay range may vary from the range posted.