Sr Manager Quality Systems

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.

     

JOB DESCRIPTION:

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.

Our location in Temecula, CA currently has an opportunity for a Senior Manager, Quality Systems

The Opportunity

This position works out of our Temecula, CA location in the Abbott Vascular Division.  Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.

What You'll Work On

Job Summary

Lead the team to establish and implement a dynamic structure that fosters and ensures consistent compliance to external laws, regulations, guidances and standards (LRGS) that affect the quality system. The team will develop and follow a process to implement a structure that will facilitate a consistent implementation of external quality system LRGS. This structure will improve coordination between functions and increase the awareness and compliance of external requirements.

Main Responsibilities

• Recruits, coaches and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. Creates an entrepreneurial environment. Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
• Coordinate the implementation of quality system requirements at Abbott Vascular and Abbott Vascular affiliate locations.
• Monitors compliance of company policies and procedures (e.g. compliance with FDA, Canada, Australia, Brazil, Japan, European Union, and other global regulations).
• Manages quarterly Management Review activities for the Division and ensures accurate information is provided at the corporate level
• Ensures compliance with FDA and global regulatory agency requirements for manufacturing site registrations and device listings
• Keeps the organization's vision and values at the forefront of decision making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
• Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Participate in international standards/regulations review and comment.
• Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
• Provides leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives.
• Creates immediate to long-range plans to carry out objectives established by top management.
• Forecasts future departmental needs including human and material resources and capital expenditures.
• Recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.
• Assignments are expressed in the form of objectives.
• Makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.

Required Qualifications

Bachelor's degree and 9+ years of related work experience or an equivalent combination of edu