QARA Project Manager

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.

The Opportunity

This position works out of our Alameda, CA location in the Lingo Division. 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. 

As an individual contributor, the Quality Assurance and Regulatory Affairs (QARA) Project Manager combines knowledge of business objectives, quality system process, and regulatory compliance matters to drive improvement initiatives. The individual has department/group/site level influence and is generally recognized as an expert resource within the department. 

What You’ll Work On

•    Organize and/or Lead QARA driven initiatives, work plans, and team meetings.  Work with QARA Leadership to manage conflicting priorities and resource limitations.  Attend cross functional meetings for operational initiatives and product maintenance (both software and hardware). 
•    Organize subject matter experts to identify, develop and implement new quality and regulatory policies and procedures   
•    Identify and execute implementation plans, including resource needs, deliverables, training, and go-live.
•    Exercises independent judgement regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management.
•    Develops, communicates, and builds consensus for operating goals that are in alignment with the division.
•    Provides leadership by communicating and providing guidance towards achieving department objectives.
•    Interfaces with a variety of management levels on significant matters, often requiring the coordination of activity across organizational units.
•    Anticipate risks and obstacles throughout projects and develop solutions with team members
•    Provide proactive, diligent, and fact-based communication to Sr. Management, peers, and team.
•    Creates immediate to long-range plans to carry out objectives established by top management. 
•    Create and review quality system documentation products as they apply to projects and areas of responsibility.
•    Acts as a mentor to less-experienced staff.
•    Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and proactive improvements.
•    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.

Required Qualifications

•    Bachelor’s Degree, preferably in Technical Field, Life Science, or closely related discipline.
•    4+ years’ experience managing projects in a regulated industry, leading cross-functional and/or cross-divisional project teams
•    Prior experience in the development and implementation of policies and standard operating procedures a must
•    Understanding of medical device regulations (incl: device classifications and risk categorization)  

Preferred Qualifications

•    M.B.A. or a Masters degree in a Quality or Regulatory discipline is preferred
•    Knowledge of Jira, Confluence, Monday.com, and/or other web-based project management tools is a plus.  
•    Professional certification (PMP, ASQ, RAC) a plus.

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.

The base pay for this position is

$112,000.00 – $224,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Regulatory Operations

DIVISION:LNGO Lingo

LOCATION:United States > Alameda : 2901 Harbor Bay Parkway

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

TRAVEL:Yes, 10 % of the Time

MEDICAL SURVEILLANCE:Not Applicable

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf