Senior Manager Supplier Quality

Abbott (abbottcareers2 board); United States; On-site; USD 129,000 - 259,000; Full time

Job summary

Abbott in Austin, TX, within the Diabetes Care group, leads quality systems for U.S. third party manufacturing to ensure TPM performance and regulatory compliance. The role oversees CAPA, change control, batch release and audits, while supporting product compliance queries and audit preparations.

The position emphasizes staff management, diverse hiring practices, and ongoing quality system maintenance to meet corporate standards and timely outcomes.

Qualifications

• Bachelor's degree and minimum 7 years of experience in quality or related field.
• Strong business acumen and cross functional experience (quality, engineering, opex).
• Experience dealing with regulatory authorities such as FDA.

Responsibilities

• Manage the Quality System for US third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance.
• Nonconformance and CAPA.
• Change control.
• Complaints.
• Batch release.
• Label development and control.
• Related budget elements.
• Management reviews.
• Audits.
• Provide quality support for questions related to products compliance queries, complaint investigation, nonconformance and compliance audit preparation.
• Ensure TPM related Quality Assurance policies and procedures are implemented.
• Maintain quality system infrastructure and standards at US TPMs.

Skills

Quality management

Regulatory knowledge (FDA)

Leadership

Cross-functional collaboration

Education

Bachelor's degree

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 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 Austin, TX location in the Abbott Diabetes Care division where we are 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.

What You'll Work On

Manage the Quality System for US third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance.

• Nonconformance and CAPA
• Change control
• Complaints
• Batch release
• Label development and control
• Related budget elements
• Management reviews
• Audits

Provide quality support for questions related to products compliance queries, complaint investigation, nonconformance and compliance audit preparation.

Ensure implementation of TPM related Quality Assurance policies and procedures generated conform to predetermined Corporate/Division standards and specifications.

Ensure quality system infrastructure and standards are in place and maintained at US TPMs to meet compliance and timeliness requirements. This is done through the quality systems monthly reviews and MOS tier process, ongoing business maintenance, and tracking and trending.

Effectively identifies and develops staffing requirements: -Develop practices that ensure a diverse work force and improved job performance.

Manage a staff to support batch release, inventory turns, product holds and multi system product traces.

Required Qualifications

Bachelor's degree and minimum 7 Years of experience, both overall and any industry specific experience needed.

Strong business acumen and cross functional experience (quality, engineering, opex).

Experience in dealing with regulatory authorities such as FDA.

Managerial/leadership experience.

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

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The base pay for this position is $129,300.00 - $258,700.00 In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: ADC Diabetes Care

LOCATION: United States > Texas > Austin : 12501B Research Boulevard

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: No

MEDICAL SURVEILLANCE: No

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)