Edwards Lifesciences is driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives.
Provide leadership and management of the site laboratories (e.g., Microbiology, Chemistry) including sterility assurance, production support and environmental monitoring in support of production operation.
• Manage a team within a site laboratory (e.g., Microbiology, Chemistry) including responsibilities for the development, validation and implementation of laboratory test methods to support production, new product transfers, and product release activities. Responsible for site laboratory budget, and assessing, improving, and ensuring laboratory equipment, methods and systems meet quality and regulatory requirements. Ensure staff have appropriate education, training, and experience to perform assigned responsibilities. Drive a culture that is focused on quality and business results. Create an environment that fosters employee motivation and engagement.
• Lead in identifying risk, developing mitigation strategies, defining alternative solutions, and resolving issues in collaboration with cross functional groups.
• Responsible for providing subject matter expertise and technical support on product and process investigations.
• Develop robust talent development plan in alignment with functional growth strategies of the department.
• Responsible for ensuring laboratory specific investigations are performed in compliance with quality and regulatory requirements.
• Lead efforts to optimize laboratory processes and systems by assessing business needs and developing, proposing and implementing technology solution options.
• Actively participate in the EW Global Laboratory council to help drive consistency and improvement and lead initiatives across laboratory network.
• Other incidental duties
Education and Experience:
Bachelor's Degree in in related scientific field (e.g., chemistry, biology or microbiology)related experience within applicable regulated laboratory required and skill levels exceeding the requirements of the previous level
Experience in Quality and/or Compliance management in the medical device, pharmaceutical industry, or the equivalent
Demonstrated track record in effective laboratory management, including compliance, technical excellence, and organizational development Required
• Proven successful project management leadership skills
• Proven expertise in both Microsoft Office Suite and related systems
• Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making
• Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Expert understanding of quality laboratory and technical procedures while identifying applications of functional knowledge and existing methodologies to complex problems
• Expert understanding of related aspects of quality laboratory processes and/or systems
• Expert knowledge of FDA Quality System Regulations, Good Laboratory Practices (GLP) and ISO/EN standards
• Knowledge of financial acumen as it relates to the business as well as quality laboratories
• Demonstrated ability to manage teams and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations
• Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality laboratories to the business
• Serve as core partner to senior leaders in Business Units, Functional Groups, and Regions
• 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 work and excel within a fast paced, dynamic, and constantly changing work environment
• Frequently interacts with internal and external management and senior-level customer representatives concerning projects, operational decisions, scheduling requirements, and/or contractual clarifications
• Lead briefings and technical meetings for internal and external representatives
• Require the ability to change the thinking of, or gain acceptance from others in sensitive situations, without damage to the relationship
• Dedicated to quality client service and pro-active and responsive to client needs.
• Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.
• Provide leadership and direction to cross-functional teams to successfully implement global enterprise systems and related solutions
• Develop relationships and leverage them to influence change
• Support and solicit input from team members at all levels
• Adhere to all EHS rules and requirements 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
10 % International
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.