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

JOB DESCRIPTION:

CAPA Manager

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

This position works out of our Irving, TX location in the Transfusion Medicine (TM) Division. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments and informatics systems are often the first step in patient care decision making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As the CAPA Manager, you'll represent TM as the Global Process Owner for CAPA and is responsible for developing, establishing, and maintaining CAPA subsystem, policies, processes, procedures, training materials and controls enhancing the performance and quality of products and the divisional capability to demonstrate conformance to established standards and agency regulations.

What You'll Work On

• Provide expert level guidance and direction of the CAPA systems Body-of-Knowledge.
• Provides subject matter expertise, leadership, and training on investigational & Root Cause Analysis techniques, as appropriate, to other CAPA team members and to technical subject matter experts involved in the resolution of quality issues
• Supports all audits and regulatory inspections across TM locations, as a global CAPA subject matter expert
• Represent Quality Systems as required in support of cross-functional divisional projects. Identify Quality Initiatives and lead cross-functional teams to complete them
• Provide influential leadership with international sites to drive proactive quality system improvements.
• Provide diligent and fact-based communication to Executive Management team, peers, and team on Quality Systems initiatives and changes.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
• Ensure all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
• Produce and analyses trend metrics and reports and establishes further actions, as may be required.
• Represents the TM CAPA organization on Interdivisional committees and Communities of Practice to drive continues improvement across the corporation.
• This position will serve as a functional representative for organizational initiatives potentially impacting or affecting the QMS.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment. Provide management and development of the CAPA management staff.
• Accountable to the Quality Organization for achieving mutually agreed upon objectives.
• Influence and visibility extend beyond immediate organization and grade level, including international sites, ADD & Corporate and Divisional Management across Abbott.
• Position involves interactions across multiple functional areas including operations, R&D, Marketing, Supply Chain, Quality and Regulatory.
• Compliance activities are of the utmost importance to our business.
• The CAPA System is a key inspection focus of worldwide regulators and auditors.
• The system must be usable, simple, sustainable, and well maintained; Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls.
• Decisions and recommendations made by this position directly influence and impact the quality of marketed products and the effectiveness of ADD's Quality System to applicable regulations.

Required Qualifications

• Bachelor's Degree or an equivalent combination of education and work experience.
• Minimum of 9+ years experience.

Preferred Qualifications

• Bachelor's Degree preferably in a technical/scientific discipline e.g., Chemical, Physical or Biological Sciences, Pharmacy, Microbiology, Medical Technology, Engineering
• Masters Degree preferred.
• Experience in a Quality or Technical area, including two years of direct supervisory experience. Experience should include quality, technical product support and /or development, budgetary responsibility, and functioning in a matrix-managed environment.
• Knowledge of regulations and standards affecting IVDs and Biologics.
• Demonstrated organizational influence to include, but not limited to compliance excellence, organizational improvement, product-related risk mitigation, and/or manufacturing cost reduction.
• Medical Device manufacturing experience (FDA Class III preferred).
• Demonstrated extensive experience with Domestic and International regulatory requirements and regulating bodies.
• Strong project management, team skills, and influential management.
• Experience working in a broader enterprise/cross division business unit model.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to travel internationally.

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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 and @AbbottGlobal.

The base pay for this position is

$90,700.00 - $181,300.00

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

JOB FAMILY:

Operations Quality

DIVISION:

TM Transfusion Medicine

LOCATION:

United States > Irving : LC-02

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), Work requiring repeated bending, stooping, squatting or kneeling

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