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.