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 109,000 colleagues serve people in more than 160 countries.
ABOUT ABBOTT DIAGNOSTICS:
The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott’s life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.
Our pioneering technology spans the world of healthcare operations — with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.
Our location in Lake Forest, Illinois currently has an opportunity for a Director, Operations, Product & Process Support.
WHAT YOU’LL DO:
The Director, Operations, Product & Process Support is within the ADD IA/CC Technical Operations and Innovation organization. This role will develop strategies and direct implementation of manufacturing and process improvement activities to meet production schedules, quality standards, and cost objectives in a regulatory environment. The incumbent directs strategies and tactics to support on-market issue resolution in complex diagnostic/biological systems that conform to the Quality System Regulations and meet customer requirements; identifies and executes continuous improvement opportunities. Communicates with senior management to provide regular updates on product and process health and to align execution plans, ensuring business strategies are met.
Assay Technical Knowledge: provide investigational independent review and oversight to site Technical Support teams, focusing on product and process design, process capability, and analytical method design.
Solicit input for alternative approaches to resolve critical business issues.
Use sound judgement, appropriate scientific methods, and thorough data analysis.
Responsible for the activities to manufacture product to design requirements, FDA guidelines and operating procedures.
Support CAPA, root cause analysis, metrics, CAPA Review Board and resolution of on-market product quality issues globally across ADD’s business.
Advise and assist the Director and DVP of Operations in the business continuity and manufacturing strategy for areas of responsibility. Provides a quick, detailed assessment of the problem, outlining the scope and magnitude of the issues. Coordinates Quality, Regulatory, and Operations teams as needed, presents long and short term options, solve problems with minimal disruption to operations and develops policies to minimize recurrence and provide guidance and oversees work of other Technical Support specialists when needed.
Develop key performance indices, set goals and develop plans for continuous improvement in quality, cost, employee performance, and maintains a high level of employee safety.
Manage financial costs and look for cost effective solutions.
Maintain and support methods used in manufacturing.
Participate in strategy development and translate strategy into specific actions. Ensure projects are completed within time and compliantly. Establish team goals and plans to meet them.
Supports audits of manufacturing facilities.
Participate in new product design and development reviews and design control activities effecting manufacturing.
Utilizes, harmonizes and supports product monitoring at the site and Division level to monitor assay health and drive continuous improvement.
Coordinates cross-functional review meetings across technical organizations within manufacturing sites. Connects dots, share best practices, assess talent / skill depth
Coordinates with additional functional teams (R&D, ATM, etc) for significant/complex technical issues.
EDUCATION AND EXPERIENCE YOU’LL BRING:
Bachelor's degree and 12+ years of related work experience or an equivalent combination of education and work experience. PhD in biochemistry or related field preferred.
Minimum 5 years of manufacturing experience with companies engaged in the manufacture of high quality, FDA regulated products.
Knowledge of regulations and standards of medical devices. Experience with ISO 9001/CE Mark requirements. Manufacturing management experience in manufacturing planning, documented systems, GMP, and quality.
Proven leadership skills, results oriented, highly collaborative, team player, and self-starter who can operate in a fast pace environment. Experience in state-of-the-art, multi-step, high volume, process control manufacturing and process development.
10 years of operations / R&D experience
5 years of people management experience in diagnostics or medical device management.
Experience in assay TPD and/or system integration desirable. Cross-functional management experience in manufacturing, R&D, quality/regulatory, and marketing relationship desired.
WHAT WE OFFER:
At Abbott, you can have a good job that can grow into a great career. We offer:
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
- Paid time off
- 401(k) retirement savings with a generous company match
- The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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.