Senior Manager Good Manufacturing Practices

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:

Sr. Manager Good Manufacturing Practices

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

Abbott Diabetes Care has an opportunity for a Sr. Manager Good Manufacturing Practices. The Sr. Manager Good Manufacturing Practices leads strategy, management and support for global supplier quality associated with the division. Areas include suppliers (parts and services), Third Party Manufacturers (TPM), and Original Equipment Manufacturers (OEM), service providers and consultants. Establishes quality systems and plans for supplier controls to assure design, development and manufacture of the highest quality products to exceed customer requirements. Interfaces with outside regulatory agencies.

What You'll Work On

• Oversees the strategy implementation and operations for performing detailed audits of practices at company manufacturing plants and sites to ensure that policies and procedures comply with guidelines set forth by all applicable regulations both domestic, international, and applicable International Standardization for Organization (ISO) standards.
• Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions.
• Consults with manufacturing management to establish practices and procedures that comply with all applicable regulations.

• Champions quality and compliance through awareness of requirements, trends and other external influencing factors especially in the area of supplier management.
• Builds strategic partnerships with internal and external stakeholders to further departmental and organizational objectives.
• Establishes a progressive supplier quality vision and strategy by recognizing situations and anticipating at a broad industry level and influences strategic decision making beyond own functional area.
• Recruits, coaches and develops talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Management of supplier audits, divisional budget, qualification, incident resolution, metric reporting and validation for division products and parts (e.g. meters, sensor assemblies and accessories).
• Third Party management of domestic and international sites for finished device manufacturing including yield and quality data reports, finished device acceptance, validation, external inspections, incoming, equipment calibration and maintenance activities.
• Management of third party service providers for offsite inspections and miscellaneous quality activities.
• Managing and acceptance of Third Party Manufacture of products (e.g. meters, readers, sensor devices and accessories).
• Analyzes data and provides recommendations to senior staff regarding supplier quality related crises.
• Quality Management System (QMS) responsibility for TPM ensuring robust compliance and alignment with FDA, ISO, cGMP, etc
• Lead continuous improvement initiatives within the QMS framework.
• Manage TMP relationship with respect to Quality
• Support audits, respond to quality concerns, and provide data transparency.
• Ensure product release criteria meet specifications and customers' expectations.
• Coordinate CAPA (Corrective and Preventive Actions) processes for ADC
• Maintain audit readiness at all times.
• Support and lead divisional initiatives as required
• Influence the TPM organization to strive for excellence in everything they do

Required Qualifications

• B.S. in Engineering or equivalent combination of education and work experience.
• Masters degree preferred
• Minimum 10-12 yrs experience in Medical Device industry
• Minimum of 4-6 yrs of experience in a Quality role in Medical Device industry
• Substantial knowledge of FDA and ISO Quality System Requirements and other applicable US Code of Federal Regulations for Devices.

Preferred Qualifications

• Ability to guide cross functional resources to ensure program deliverables are effectively executed and that design control and quality system requirements are met.
• Ability to support efficient decision making by Sr. Management by providing scenario analysis, risk identification and contingency plans.
• Ability to execute project planning tools to support product development programs and ensures site wide communication of program status to drive engagement of staff.

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

Diabetes

We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.

The base pay for this position is
$127,300.00 - $254,700.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Operations Quality

DIVISION:
ADC Diabetes Care

LOCATION:
United States > Flex Buffalo Grove : 700 Corporate Grove

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), Continuous standing 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