QMS Lead - Global Commercial Quality & US Commercial Quality Lead

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 Title

QMS Lead -Global Commercial Quality & US Commercial Quality Lead

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

Our location in Lake Forest, IL currently has an opportunity for a

QMS Lead -Global Commercial Quality & US Commercial Quality Lead.

The QMS Lead -Global Commercial Quality & US Commercial Quality Lead has two key roles to play- Leading the QMS for the ID Global Commercial Quality Organization and Managing the Commercial Quality operations for the US market.

WHAT YOU'LL DO

QMS Lead role:

Provide strategic and functional Quality System oversite to the Commercial Quality team that ensures compliance to applicable quality, regulatory, applicable GxP regulations and Abbott procedures. requirements. This job function has accountability for complying with the applicable elements of the Corporate Quality Management System (QMS).

Commercial Quality Operations role:

Responsible for implementing the Quality and Regulatory requirements; driving compliance to Abbott Global Quality/Regulatory Framework, Business Unit Policies/ Procedures, and managing the quality operations for the US market as part of the regional team.

QMS Lead Role

Responsible for leading Global Quality Systems for the ID Commercial Quality team with direction from the Corporate Quality Systems and Business unit Quality Systems teams.

Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.

Ensure compliance for the Global Commercial Quality teams with applicable policies, processes, and procedures, contributing to the development of strategies and oversight of the QMS at the affiliates.

Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.

Responsibility to understand, maintain, and drive awareness of the quality consequences which may occur from the improper performance of their specific job.

Responsible for developing, implementing, and maintaining the effectiveness of the quality system

Owner of the Management Review process and related metrics tracking and trending. (Quality Documentation, Training and Supplier /Distributor Quality).

Drive implementation of policies and procedures to maintain compliance to global regulatory requirements for policies, processes, and procedures.

Responsible for quality oversight in the area of GxP document management and retention.

Manage broad and cross-functional quality programs, initiatives and organizational change related to the Commercial Quality.

Responsible for Training and for the establishment, administration, and maintenance of a Commercial Quality training program.

Responsible for Documentation strategy and for administration and maintenance of documentation control quality programs such as: Document Change Control, Document Retention, etc.

Responsible for Supplier Quality and for the establishment, administration, and maintenance of a supplier quality programs such as: CAPA system oversight, Supplier Quality Management and Supplier Qualification.

Responsible for Audit schedule management, Approved Distributor and Supplier list maintenance.

Establish and oversee global CAPA governance.

Develop CAPA trending capabilities, enabling the identification of systemic root causes leading to the implementation of solutions to eliminate root causes.

Establish defined thresholds enabling the tracking/trending of escalated issues across the QMS holistically inclusive of QI/CAPA escalations.

Appropriately escalate individual CAPAs at risk and/or negative trends in Key Performance Indicators to the appropriate forums and management

Oversee the planning, execution and delivery of CAPA strategies/plans for the remediation, correction and prevention of recurrence of those significant quality events with broader impact across the Global Commercial Quality.

Support investigation of large-scale significant quality events, including the identification of issues, impact assessment, root cause analysis, oversight of appropriate communication and escalation to senior leadership, as appropriate

Establish and drive the use of accurate and actionable metrics for Global Commercial Quality.

Provides oversight to the electronic quality management systems, including document management and learning management systems for Global Commercial Quality.

Performs periodic reviews of the QMS to document and report gaps and risks.

Participate or chair relevant Project team meetings.

Perform other duties and projects as assigned.

Commercial Quality Operations Role

Responsible for implementing the Quality and Regulatory requirements; driving compliance to Abbott Global Quality/Regulatory Framework, Business Unit Policies/ Procedures, driving the establishment of operations Quality System.

Maintain QMS in the market and continually evaluate and monitor the quality system for suitability and adequacy for the commercial business.

Support Local Quality leader in areas of quality decisions, such as escalations, field actions and/or other significant quality issues.

Interface with Tech Services and Legal Manufacturers on Quality Complaints for Abbott products, ensuring timely investigation, resolution,

closure & customer follow-ups. Proactively reviewing product complaints and address the trends in a timely manner.

Collaborate with other global entities in fulfilling Field Corrective actions (FCA) resulted from Regulatory Field Safety Notifications.

Provide relevant quality support for post market surveillance (PMS) activities, ensure timely executions to minimize, any product supply interruption.

Facilitating Audits (Corporate Quality Audits, Regulatory Audits, ISO-Notified Bodies), as applicable.

Review Changes, Deviations, Investigations, Market Complaints & CAPA.

Responsible for the Quality Control program for imported products that are distributed in the market

Responsible for administration of and compliance with all major quality system activities including but not limited to document control, record control, training, CAPA, quality incidents, risk management and internal audit.

Continuously drive for compliance with Abbott quality standards and regulatory requirements.

Responsible for management and satisfactory resolution of product issues in a timely manner.

Coordinate cross-functionally to ensure implementation of containment, mitigation, remediation and corrective activities as necessary.

Coordinate with entity management and facilitate Quality Management Review activities, including quarterly quality objective reporting, escalation of issues with QMS impact and closure of open actions from previous meetings.

Responsible for coordination and management of site Quality metric tracking, trending and reporting activities.

Assure metrics appropriately characterize the key performance indicators of the quality system.

Responsible for supporting for internal compliance and 3rd party audits / inspections.

Coordinate and manage all commercial audits in conjunction with the Commercial Quality lead.

Implement new or modify existing processes to maintain compliance with local entity, business unit, division, corporate, voluntary standards and regulatory requirements.

Required Qualifications

Bachelor Degree in Pharmacy/Science/Engineering, or other related discipline.

Must have been employed in the Medical Device/Pharma/IVD industry for a minimum of 6 years.

Minimum of 10 years' experience in Quality Assurance and /or Compliance in a regulated industry.

Experience in managing a dedicated QMS development role in healthcare industry is desirable.

Ability to effectively communicate in English.

Preferred Qualifications

Demonstrated leadership/management skills with respect to achievement of company goals & objectives.

Experience working in a broad enterprise/cross-division business with the ability to work in a highly matrixed and globally diverse business environment.

Prior quality systems management experience, preferably in the Medical Device/IVD industry.

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.

The base pay for this position is $111,300.00 - $222,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com