Senior Manager, Quality Systems - Lingo (on-site)

RXinsider LTD.; Alameda (CA); Hybrid; USD 131,000 - 261,000; Full time

Job summary

Abbott is seeking a Senior Manager, Quality Systems to ensure the effectiveness of the quality system and compliance with LRGS. This on-site role in Alameda, CA drives process rigor, coordinates between functions, and implements a scalable quality structure across Abbott Lingo.

The ideal candidate has a strong background in quality systems, regulatory knowledge (FDA/ISO/EN), and experience leading teams in a regulated medical-device environment.

Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience.
• 7–9 years related work experience.
• Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
• Monitors costs of projects and of human and material 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.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
• Investigates and solves problems that impact work processes and staff within or across units or departments.
• Communicates the departmental vision for the organizational unit assigned.

Responsibilities

• Recruit, coach and develop organizational talent.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Create an entrepreneurial environment.
• Provide direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• May manage and coach a team of quality assurance employees.
• Keep the organization's vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership.
• Build 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.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Make decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Develops, monitors and appropriately adjusts the annual budget for department(s).
• Coordinate the implementation of quality system requirements at Abbott Lingo.
• Assess proposed regulations and communicate new requirements to the organization.

Skills

Leadership

Verbal & written communication

Analytical thinking

Problem solving

Regulatory awareness

Quality systems

Education

Bachelor’s Degree or equivalent

Job description

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 115,000 colleagues serve people in more than 160 countries.

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
• 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 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 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

Personalized healthcare is the future. Working on Lingo, you will help build a next-generation technology that enables individuals to make decisions about how to improve energy, lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott, a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.

We are recruiting for a Senior Manager, Quality Systems to join our team on site in Alameda, CA. In this role, you will ensure effectiveness of the quality system and consistent compliance to external laws, regulations, guidances and standards (LRGS). Implement and manage a structure that will facilitate a consistent implementation of quality systems. Maintain coordination between functions and increase the awareness and compliance within the quality systems processes.

What You’ll Work On

• Recruit, coach and develop organizational talent.
• Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Create an entrepreneurial environment.
• Provide direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments.
• May manage and coach a team of quality assurance employees.
• Keep the organization's vision and values at the forefront of decision making and action.
• Demonstrate effective change leadership.
• Build 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.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Make decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Develops, monitors and appropriately adjusts the annual budget for department(s).
• Coordinate the implementation of quality system requirements at Abbott Lingo.
• Assess proposed regulations and communicate new requirements to the organization.

Required Qualifications

• Bachelor’s Degree or an equivalent combination of education and experience
• Minimum 7 - 9 years related work experience.
• Provides direction and monitors progress of exempt specialists and/or supervisory staff toward departmental goals.
• Monitors costs of projects and of human and material 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.
• Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups
• Investigates and solves problems that impact work processes and staff within or across units or departments.
• Communicates the departmental vision for the organizational unit assigned.

Preferred Qualifications

• Advanced degree
• Submission / registration types and requirements
• Effective verbal and written communication with diverse audience and team.
• Analytical thinking with good problem-solving skills.
• Experience managing and leading a team.
• Certification is a plus (such as ASQ).
• Must be able to lead and manage multiple and competing priorities and manage programs.
• Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
• Experience with medical device software requirements and software regulations.
• Ability to identify risk areas and elevate issues as appropriate.

Apply Now

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is $130,700.00 – $261,300.00. In specific locations, the pay range may vary from the range posted.