Senior Manager Supplier Quality

Abbott; Austin (TX); On-site; USD 129,300 - 258,700; Full time

Benefits offered by this job

Career development

Free medical coverage

Retirement savings plan

Tuition reimbursement

Diversity recognition

Job summary

A global healthcare leader in Austin, TX is seeking a Quality System Manager for the Diabetes Care division. This role focuses on enhancing compliance for third-party manufacturing, managing regulatory standards, and leading audits. The ideal candidate will have a Bachelor's degree and over 7 years of relevant experience, including interactions with regulatory authorities like the FDA. The position offers a competitive salary range of $129,300 to $258,700, reflecting the importance of this role within the organization.

Qualifications

• Minimum 7 years of overall experience.
• Experience in any industry specific experience needed.
• Strong experience dealing with FDA.

Responsibilities

• Manage the Quality System for US third party manufacturing.
• Ensure overall TPM performance and compliance.
• Provide quality support for compliance queries and audits.

Skills

Business acumen

Cross functional experience

Regulatory authority experience

Managerial skills

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.

This role manages the Quality System for third party manufacturing in accordance with Corporate and Divisional standards to ensure overall TPM performance and compliance. The role is responsible for keeping all the QS elements consistent and effective for its purpose. Ensures implementation of TPM related Quality Assurance policies and procedures generated conform to predetermined Corporate/Division standards and specifications.

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.

Systems include

• 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.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives : https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

Abbott is an Equal Opportunity Employer, committed to employee diversity.

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.