The Opportunity
This is an onsite role located in 1420, Harbor Bay Parkway, Alameda, CA. This is not a remote role/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.
Core Job ResponsibilitiesStrategic Business Relationship Management
- 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.
Demand Shaping, Portfolio Alignment and Capability Planning
- 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.
Quality Process and Systems Leadership
- 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
- Bachelor’s 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.
Minimum Experience / Training Required
- 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.
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.
The base pay for this position is
$130,700.00 – $261,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:IT Services & Solutions Delivery
DIVISION:BTS Business Technology Services
LOCATION:United States > Alameda : 2601 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
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)
