Sr Manager, Business Solutions

Innovation starts from the heart. At Edwards Lifesciences, we’re dedicated to developing ground-breaking technologies with a genuine impact on patients’ lives. At the core of this commitment is our investment in cutting-edge information technology, supporting global innovation and collaboration. As part of our IT team, your expertise will help facilitate our patient-focused mission by developing and enhancing technological solutions.

About the role

The Sr. Manager for Digital Quality will manage the sustainability aspects of the ePAC Program. This role collaborates cross-functionally with various organizational areas to develop a deep understanding of how Product Distribution Compliance enables Marketing, Regulatory, Labelling, Supply Chain, and Quality Processes. The successful candidate must combine analytical skills, project management expertise, and business acumen to think enterprise-wide and support global operations. This role involves interacting with upper management, enforcing governance, and providing expertise in developing technical solutions to optimize processes and systems.

Responsibilities

• Oversee the reengineering and optimization of complex business processes across multiple systems and business functions.
• Act as a Subject Matter Expert (SME) in business processes within the area of responsibility.
• Evaluate and validate complex functional business requirements against business needs.
• Translate business needs and articulate functional designs to meet requirements.
• Serve as a liaison between multi-functional team members and external stakeholders.
• Lead efforts to reengineer and optimize complex business processes and systems.
• Identify root causes and provide guidance for resolutions, including testing and validation of processes and systems.
• Perform complex root cause analysis and troubleshoot business processes, including testing and researching data integrity/accuracy.
• Provide design and architecture guidance to project teams for tactical projects/initiatives.
• Provide leadership and guidance to business solutions administrators on best practices.
• Offer platform guidance to team members on solutions.
• Identify and recommend innovations that significantly enhance the efficiency and effectiveness of business processes.
• Perform other incidental duties.

Requirements

• Bachelor's Degree in a related field.
• 10 years of previous related experience or equivalent work experience based on Edwards criteria.
• Certification in related disciplines.
• Experience documenting technical design and requirement definition documents used to implement system capabilities.

Qualifications

• Stay current with the latest platform features.
• Experience managing Compliance Systems in the medical device, pharma, biotech, or healthcare-related industries.
• Ability to evaluate and analyze moderately complex technical information and global regulatory data, identify driving factors, and recommend courses of action.
• Comfortable interfacing with multiple stakeholders to define acceptance criteria, create use cases, and perform acceptance testing.
• Comfortable presenting training materials to system stakeholders.
• Ability to learn and map both business unit and country/region-specific product distribution processes.
• Proven successful project management skills.
• Excellent documentation, communication, and interpersonal relationship skills, including negotiating and relationship management to drive achievement of objectives.
• Recognized as an expert in own area within the organization.
• Expert knowledge in at least one discipline (e.g., Analysis, Design, Development, QA/RA).
• Extensive technical knowledge with expertise in at least one technical language or data management system (e.g., Oracle, SQL Server).
• Expert knowledge of Regulatory Information Management Systems and integration points, including governing regulations and related government databases (GUDID, UDI).
• Strict attention to detail.
• Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management.
• Ability to manage competing priorities in a fast-paced environment.
• Represents leadership on projects within a specific area, interfacing with project managers and teams.
• Consult in project settings within a specific area.
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules).

Pay

For California (CA), the base pay range for this position is $139,000 to $196,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

Benefits

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.