Senior Manager Quality Operations

Senior Manager Quality Operations

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 Core Lab 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 Senior Manager Quality Operations, you’ll effectively develop, execute, and manage the Quality Assurance Department in accordance with Corporate and Divisional policies and procedures in order to assure that proper controls are instituted and maintained.  The manager has overall responsibility to maintain high quality levels on all products while achieving high efficiency.  The manager must provide leadership for Global QA initiatives to implement quality systems/processes across the organization and Division achieving quality improvements, cross plant consistency, and regulatory compliance.  The manager is responsible for product related decisions including acceptance, release, and production related assessments, events or complaints.

What You’ll Work On

• Effectively manage/develop the department staff to conduct quality assurance projects simultaneously to ensure that all operational & compliance aspects meet planned dates.

• Ensure department programs and quality system documents meet corporate and regulatory requirements to provide sufficient oversight to avoid regulatory vulnerability and regulatory action.

• Support plant quality assurance, operations and purchasing groups globally to ensure that proper incoming material documentation (CAPA, acceptance plans and specifications) are compliant to Corporate, Division, and regulatory requirements.

• Reviews performance of the department and personnel against approved objectives, budgets, and plans, and takes necessary remedial actions.

• Insures that required records and documents, including formula test results, inspections, file samples, vendor performance, product complaints, product disposition, regulatory inspections are maintained.

• Manage the department operating model to support the program execution, performance monitoring and continuous improvement processes.

• Execute the qualification of products to assure that Division programs and initiatives are met.

• Provide operational support to division global operations by conducting event management.

• Utilize monitoring policies and procedures to assure that all products generated conform to predetermined Corporate/Division standards and specifications.

• Creates, implements, and/or supports development programs for the continuous improvement of vendors to achieve sustainable performance which meets Division requirements.

• Engages in cross functional partnerships on new product introductions/innovations which drive business growth and/or compliance initiatives.

• Establishes and implements Quality Assurance policies and procedures for inspecting and controlling raw or packing materials and assaying in-process and finished product to ensure that all products generated conform to predetermined Corporate/Division standards and specifications.

• Manages departmental human and physical resources to maximize efficiency and company investment.

• Conducts value analyses to optimize use of these resources.

• Reviews performance of the department and personnel against approved objectives, budgets, and plans, and takes necessary remedial actions.

• In conjunction with Division Compliance, monitors facilities and manufacturing operations for conformance with established procedures and requirements of regulations.

• Insures that required records and documents, including formula test results, inspections, file samples, vendor performance, product complaints, product disposition, regulatory inspections are maintained.

• Supports plant and Division activities in introducing new products through the plant and clinical products for testing and data evaluation.

• Supports major plant project expansions and new products to assure proper technical input and regulatory requirements.

• Management oversight for TPM laboratories which include chemical, biological, sterility and environmental testing.

• Interfaces with Division to understand and troubleshoot product complaints and improve customer service/product performance.

• Responsible for the plant validation program and assures that it is consistent with division validation policies.

• Provides a Vendor Quality oversight to assure that suppliers have appropriate quality systems and process controls to guarantee the delivery of usable inventories of the needed quality.

• Conducts performance reviews, develops growth plans, interprets, implements, and supports employee-related policies, procedures, and programs.

• Assigns projects/tasks to direct staff.

• Assures compliance to all procedures and policies concerning all areas of quality, regulatory, safety and human resources for all departments.

Required Qualifications

• Bachelors Degree in physical or life science, engineering, or business.  

• Minimum 10 years in Quality, Supply Chain and Manufacturing or related experience is required. 

• Minimum 5 years of supervisory management.

• Minimum 3 years in a GMP environment.  Knowledge of applicable regulatory standards and GMP requirements used in manufacturing of conventional foods, infant formulas, medical foods, and foods for special medical purposes (FSMP)

• Minimum 3 years working with quality management systems and regulatory requirements. 

Preferred Qualifications

• Masters Degree is preferred but not required.

• Candidate must have demonstrated leadership skills/competencies with track record of success.

• Excellent communication skills are also essential for this role.

• Communications skills, tack and diplomacy are critical to the performance of position requirements.

• Excellent problem-solving, decision-making skills are also critical to this position since the technology for many of Abbott's products are unique.

* 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 $118,000.00 – $236,000.00. In specific locations, the pay range may vary from the range posted.

• manufacturing operations
• continuous improvement
• quality operations
• supervisory management
• supply chain
• quality management systems
• gmp
• purchasing
• problem-solving
• regulatory compliance
• performance reviews
• quality assurance
• medical science
• business growth
• event management
• quality systems
• controlling
• cross functional partnerships
• capa
• global operations
• introducing new products
• regulatory requirements
• disposition
• operational support
• development