Quality Manager, Enterprise Systems
Quality Manager, Enterprise Systems
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$ 97300 - 194700
1 Vacancy
Job Description
JOB DESCRIPTION:
Quality Manager Enterprise Systems
About Abbott
Abbott is a global healthcare leader creating breakthrough science to improve peoples health. Were 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. Youll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical 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 bachelors 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 Abbotts 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 Youll 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 companys 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 710 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 environment
- Experience 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 diagnostics
- Broad knowledge of engineering and technical applications applied in the development of medical devices.
Learn more about our health and wellness benefits which provide the security to help you and your family live full lives:
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 on Facebook at and on Twitter @AbbottNews.
The base pay for this position is
$97300.00 $194700.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ID Infectious Disease
LOCATION:
United States > Lake Forest : J55
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
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)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: EEO is the Law link - Espanol: Experience:
Manager
Employment Type
Full-Time
Key Skills
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