IT Business Relationship Manager, Quality

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 122000 colleagues serve people in more than 160 countries.

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. Youll 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 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 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

IT Business Relationship Manager Quality will serve as the primary IT business relationship partner for the Abbott Diabetes Care (ADC) Quality function. Partners with Quality leaders process owners compliance stakeholders Enterprise Architecture Product Management and Shared Services delivery teams to align technology capabilities with Quality strategy regulatory requirements operational priorities and business outcomes.

Develops and maintains the portfolio of technology-enabled Quality capabilities initiatives and applications within the assigned scope. Acts as a trusted advisor by providing insight into technology trends business process improvement Quality systems optimization investment priorities and opportunities to strengthen compliance inspection readiness operational effectiveness and value realization.

Combines business relationship management with Quality process and systems knowledge to support Quality Management Systems (QMS) Corrective and Preventive Action (CAPA) Nonconformance Management Audit Management Training Management Document Control and Document Management Inspection Readiness and regulatory response and remediation activities. Shapes business demand and expected outcomes while Shared Services owns solution design build testing deployment and operational delivery.

• Responsible for compliance with applicable Corporate and Divisional policies and procedures.
• Translate Quality strategy operational priorities and regulatory requirements into aligned business capability and technology roadmaps.
• Build trusted relationships with Quality leaders and process owners serving as the primary IT contact for assigned Quality capabilities.
• Provide consultative guidance and align business and IT stakeholders on priorities investment choices risks and measurable outcomes.

• Lead demand shaping by qualifying business needs defining intended outcomes and evaluating opportunities before delivery commitments are made.
• Facilitate prioritization and sequencing based on strategic alignment business value compliance risk dependencies capacity and readiness.
• Develop multi-year capability and technology roadmaps current- and future-state process views and investment recommendations.
• Provide portfolio visibility and partner with Architecture Product Management Data and Analytics and Shared Services to ensure enterprise fit and sustainability.

• Maintain strong knowledge of Quality business processes regulatory requirements and supporting technology capabilities.
• Serve as a strategic technology partner for QMS CAPA Nonconformance Management Audit Management Training Management Document Management Inspection Readiness and regulatory remediation.
• Partner with Quality process owners to identify process standardization automation digitalization data and continuous improvement opportunities.
• Apply knowledge of data integrity GxP Computer System Validation (CSV) and Computer Software Assurance (CSA) when shaping technology-enabled solutions.
• Delivery Partnership and Implementation Oversight
• Communicate business priorities intended outcomes regulatory considerations and acceptance expectations to IT delivery organizations.
• Maintain alignment among Quality stakeholders Product Management Architecture delivery teams validation partners and vendors throughout the initiative lifecycle.
• Participate in governance to monitor scope risk dependencies readiness benefits and escalated issues without owning detailed solution delivery.
• Confirm delivered capabilities remain aligned with approved business outcomes Quality requirements enterprise standards and portfolio priorities.
• Compliance Audit and Inspection Support
• Maintain awareness of medical device Quality system data integrity regulatory and compliance requirements relevant to ADC Quality operations.
• Partner with Quality and Compliance teams to support audits regulatory inspections CAPA and remediation programs involving technology-enabled processes and systems.
• Support inspection readiness by coordinating understanding of system capabilities documentation controls ownership and supporting processes.
• Ensure appropriate consideration of GxP CSV CSA electronic records electronic signatures and data integrity requirements in business requirements and investment decisions.
• Value Realization Innovation and Change Leadership
• Define expected operational compliance Quality user and financial outcomes success measures and key performance indicators before investment approval.
• Facilitate post-implementation reviews to assess adoption business outcomes and benefit realization.
• Identify and shape opportunities involving automation analytics artificial intelligence digital workflows and other emerging capabilities.
• Champion business readiness and adoption and use performance data and lessons learned to refine roadmaps and future investments.

Minimum Qualifications & Education

• Bachelors degree in information systems Computer Science Engineering Quality Life Sciences Business Administration or a related discipline or an equivalent combination of education and experience. An advanced degree is preferred.

• 7-10 years of experience in Information Technology Quality Systems Quality Engineering Business Relationship Management Business Analysis Digital Transformation or related disciplines.
• Experience supporting QMS CAPA Nonconformance Management Audit Management Training Management Document Management Inspection Readiness or related Quality processes in a regulated industry.
• Working knowledge of FDA Quality System requirements GxP data integrity CSV and CSA including support for audits inspections CAPA or remediation activities.

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.

The base pay for this position is

$130700.00 $261300.00

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

IT Services & Solutions Delivery

BTS Business Technology Services

United States > Alameda : 2601 Harbor Bay Parkway

Standard

Yes 10 % of the Time

Not Applicable

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:

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