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. This supports our innovation and collaboration on a global scale, enabling our diverse teams to optimize both efficiency and success. As part of our IT team, your expertise and commitment will help facilitate our patient-focused mission by developing and enhancing technological solutions.
At Edwards Lifesciences, we're committed to operating with honesty, openness, and fairness. Compliance with the highest levels of integrity is vital to building and maintaining the many trusted relationships that sustain our reputation and credibility. Your dedication to operational excellence will ensure employee business practices meet Edwards' high ethical standards and continue to enable us to transform patient lives around the world.
The Sr. Manager for Digital Quality will be responsible for managing the sustainability aspects of the ePAC Program. This role will collaborate cross functionally with various areas of the organizations to develop a deep understanding of how Product Distribution Compliance is enabling Marketing, Regulatory, Labelling, Supply Chain and Quality Processes. The successful individual must have a combination of analytical skills, project management understanding, and business acumen with an ability to think enterprise-wide and support global operations. The Sr. Manager would be comfortable with interacting with upper management, enforcing governance and providing expertise in development of technical solutions to optimize processes and systems.
How you will make an impact:
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 in the area of responsibility.
Evaluate and validate complex functional business requirements against business needs. Translate the needs of business and articulate the functional design to meet requirements.
Serve as liaison between multi-functional team members and external stakeholders in the area of responsibility. Lead efforts to reengineer and optimize complex business processes and systems.
Lead the identification of root causes and provide guidance for resolutions for testing and validation of processes and systems, perform complex root cause analysis and troubleshoot complex business processes including testing and researching data integrity/accuracy
Provide design and architecture guidance to project teams to execute tactical projects / initiatives
Provide leadership and guidance to business solutions administrators on best practices
Provide platform guidance to team members on solutions
Identify and recommend innovations that significantly enhance efficiency and effectiveness of business processes
Other incidental duties
What you'll need (required):
Bachelor's Degree in in related field, 10 years' experience of previous related experience or equivalent work experience based on Edwards criteria
Certification in related disciplines
Experience documenting technical design and requirement definition documents that will be used to implement system capabilities.
What else we look for (preferred):
Stay current with 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 and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Recognized as an expert in own area within the organization
Expert knowledge in at least discipline (e.g. Analysis, Design, Development, QA/RA, etc.)
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 in the organization
Ability to manage competing priorities in a fast paced environment
Represents leadership on projects within a specific area interfacing with project managers and team
Consult in project setting within specific area
Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
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. 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). Applications will be accepted while this position is posted on our Careers website.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
COVID Vaccination Requirement
Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.
