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.

Quality Manager, Enterprise Systems

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 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 contributionTuition 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

As a Quality Manager, Enterprise Systems, you will be responsible for planning, directing and coordinating quality and enterprise systems programs within Abbott’s Rapid & Molecular Diagnostics (RMDx) Infectious Disease (ID) business unit. This role is chiefly focused on business and stakeholder engagement, business and enterprise systems change management, strategic planning, communications and Quality program delivery.

The Quality Manager, Enterprise Systems will champion the Quality function ensuring that the ID QA initiatives are aligned to business strategy. This role will interact with divisional leaders, RMDx shared service leads, BTS Business Relationship Managers and IT Delivery personnel, BTS leadership, site Quality leadership, and functional SMEs from across the RMDx business. This role will be accountable for the delivery of Quality and enterprise system programs, ensuring an achievable and successful outcome to the programs’ expectations.

This role will be accountable for articulating and promoting the benefits of the programs to impacted Business Units and sites, supporting them as appropriate in delivering their improvement activities. This position will work closely with the entities within ID and RMDx, as appropriate, to ensure program deliverables are well communicated and aligned to business priorities.  It will also work closely with BTS as enterprise system Business Process Owner (BPO) role, as needed, to fulfill BPO responsibilities and drive alignment with RMDx strategy.

This job function has accountability for complying with the applicable elements of the ID Quality System procedures.

What You’ll Work On

Carries out duties in compliance with established business policies and procedures.Demonstrates commitment to the development, implementation and effectiveness of applicable Quality Processes as per ISO, FDA, and other regulatory agencies.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 and maintain awareness of the Quality consequences which may occur from the improper performance of their specific job.Managing, directing and supporting the ID Enterprise Systems QA team. Effectively delegates work to direct reports and manages through to successful completion.Ensuring the coordination and delivery of Quality and systems improvement initiatives within ID.Planning, directing, and managing cross-Business Unit and cross-functional Quality and systems programs, ensuring successful outcomes in line with business strategy.Authoring and maintaining ID Quality Processes and Procedures to ensure compliance with Abbott Corporate Policies, external Quality standards/regulations, and customer (Business Unit) requirements, as needed.Supporting and directing ID sites in their alignment to ID Quality processes and procedures.Designing and delivering training of Quality system processes and enterprise systems, as required.Managing and supporting the Quality aspects of the RMDx and ID enterprise system maintenance and improvements, including: accelerating implementation of system improvements in alignment with business strategy, ensuring that all system changes are appropriately assessed and tested prior to implementation, and promoting Quality behaviors across functions throughout project activities.Develop and support a strong enterprise systems business community, engaging with SMEs and stakeholders across BUs and their sites to ensure enterprise systems meet business needs and business feedback feeds system continuous improvement activities.Providing Quality support and direction to sites and shared service functions during implementation of Quality and e-system improvements.Performing detailed Quality review and approval of Quality documents, such as process documentation, SOPs, Change Orders, and Quality records to check for accuracy, completeness, and traceability, both for new documents and for revisions.Coordination, execution, monitoring, and maintenance of Quality processes where designated as Process Owner/Subject Matter Expert, working across Divisions within Abbott to ensure ID processes are aligned with current best practice. Managing and supporting Process Owners/Subject Matter Experts to maintain and implement process improvements for applicable processes.Identifying and implementing opportunities for continuous improvement within the ID Quality System processes. Reporting of Quality metrics and KPIs to applicable Quality leadership and within the quarterly Division Management Review, as needed.Act as the key Quality liaison to ID sites.Participating as required in any Customer or Certification audit and other such inspections.Support other QMS or program activities as required.

Required Qualifications

A third-level qualification in a related field, along with 7–10 years of experience in a regulated manufacturing environment, is required.Demonstrated proficiency in recognized Quality Management Systems and comprehensive knowledge of global medical device regulations. (e.g. ISO9001/ISO13485 / ISO14971 / 21CFR820 QSR, / MDR/ IVDR /MSDSAP /cGMP etc.)Experience of working across cross-functional and global teams delivering large-scale and/or global programs.Advanced experience implementing electronic QMS software applications.

Preferred Qualifications

Certified Project Management Professional (PMP).Certified Lead Auditor.Certified ISO 13485 and/or ISO 9001 Internal Auditor.Strong technology awareness in line with technologies in use across RMDx (e.g. MS Project, MS Office, MS Visio, SharePoint).

Key Competencies

Ability to effectively direct and/or lead large-scale and global programs, ensuring business value is delivered and milestones are met, including the management of requirements gathering and refinement, appropriate engagement in IT Delivery project activities, and organizational change management execution.Ability to apply risk management principles and astute data analysis to influence decision making at the leadership and functional level.Ability to lead cross-functional business conversations and negotiate effectively with stakeholders to ensure optimal and compliant outcomes.Effective impact assessment of QMS and enterprise system changes, ensuring all are appropriately assessed and communicated.Experience in handling and delivering multiple projects simultaneously with successful outcomes that bring value to the organization.Delivering Quality projects in a complex and multi stakeholder environmentExperience in working with and leading cross-functional teams such as Quality, Regulatory, Purchasing, Supply chain, Marketing, etc.Ability to anticipate and circumnavigate roadblocks that could impede project progress and/or compliance.Team leadership experience, with direct management, mentoring, and coaching of junior resources and cross functional teams.International exposure and experience, operating across multiple time zones.Experience of working and communicating effectively with GMP-compliant sites, service delivery sites, commercial affiliates, and laboratories.Handles complexity and changing circumstances and be able to communicate effectively with wide audiences ranging from site-level personnel to senior leadership.Receptive to working in a fast-paced, constantly changing work environment that genuinely looks for those capable of stepping out of their comfort zone on a day-to-day basis. Work collaboratively and respectfully with others and be aware of cultural differences at the global level.Ability to role model compliance behaviors in all situations.Work with appropriate parties to manage and resolve Quality System and enterprise system issues, working collaboratively to create, embed and sustain compliance-focused outcomes across ID business unit and sites.Fluent business English speaker with excellent interpersonal, communication, and presentation skills.

Desirable Attributes and Skills

Experience of leading large-scale change initiatives and active stakeholder management across multiple functions.Ability to work respectfully with culturally diverse groups of people, able to communicate effectively at all levels of the business, and with both technical and non-technical people, adapting approach to suit the audience.Experience managing QA enterprise systems for medical device or in-vitro diagnosticsBroad knowledge of engineering and technical applications applied in the development of medical devices.

Apply Now

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The base pay for this position is $97,300.00 – $194,700.00. In specific locations, the pay range may vary from the range posted.