Compliance Manager Job
Job Description Job Attributes+
Abbott Park, IL, US
Yes, 10 % of the Time
40 hours per week
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
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.
This position works out of our Lake Bluff, IL (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 critical to patient care requiring blood transfusion and plasma treatments.
As the Compliance Manager, you’ll provide expert level guidance and direction of the Quality Systems to a team of Quality specialists responsible for developing, establishing, and maintaining quality systems programs, processes, procedures, training materials, and controls enhancing the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations. Aggressively identify opportunities to apply, continuously improve, and redefine quality systems and controls for all divisional product-related processes in accordance with applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc. Maintain the site to be Inspection Ready and lead internal and external audits and inspections.
What You’ll Work On
Serve as site expert on all divisional product-related processes in accordance with applicable internal, domestic, and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
Implement 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.
Represent Quality Systems as required in support of cross-functional divisional projects.
Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
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.
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.
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.
Recognizes and Quantifies Risk: Recognizes relative risks in processes and procedures and takes appropriate action.
Participates as a Team Member: Actively contributes to the team process, commits to team goals, expresses opinions, and shares ideas freely.
Fosters a Quality Attitude: 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.,
Makes Decisions: Utilizes good judgment and makes timely decisions which consider the facts and data at hand, champions specific projects, knows when to escalate to management.
Builds Relationships: Follows through on promises and commitments and maintains confidences.
Manages Personal Effectiveness: 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.
Motivates 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.
Confronts Issues: 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 Outcomes: 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.
Bachelor's Degree in Engineering or Sciences minimum, OR equivalent work experience in a related field.
Various management positions outside of Quality and/or Engineering are also required. At least three years of solid management experience is a prerequisite.
Master's Degree preferred
9 years of related work experience in quality functional roles desired with at least 3 years of direct management and supervision of personnel and resources. Management positions outside of quality are also desirable. Positions include Operations, R&D, Engineering are preferred to provide a cross functional understanding of quality issues.
Multi divisional experience also desired as this position will interface with senior quality management from all divisions and will require navigating across divisional boundaries.
Experience with external inspections e.g., FDA, FDA CBER Branch, Notified Bodies
Data Analytics used to generate metrics, e.g., PowerBI
* 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.
The base pay for this position is $118,000.00 – $236,000.00. In specific locations, the pay range may vary from the range posted.
- quality management
- quality improvement
- direct management
- quality metrics
- regulatory compliance
- project work
- performance reviews
- identifying resource requirements
- medical science
- data analytics
- responding to requests
- writing justifications
- disciplinary action
- customer requirements
- quality tools
- quality systems
- selection process
Who We Are
PUT YOUR TALENTS TO WORK
Abbott values the leadership skills developed through military service and we have a broad range of functional areas to put your talents to work. Our organization is making a difference in the lives of the people we serve with a diverse offering of healthcare products. We have a strong veteran employee community to help with your transition from the military to the corporate world.