Job Description

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.

Key Responsibilities:

• Manage and/or lead a small team within a site laboratory (e.g., Microbiology, Chemistry) including responsibilities on on-going projects within manufacturing, qualification of lab equipment, development and validation of laboratory test methods in support of production and/or new product/process development.
• Plan assigned operational and project activities with the accountability for successful completion of assigned deliverables
• Lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards and guidelines
• Analyze metrics for the organization to drive efficiency and results
• Identify opportunities and lead the implementation of changes to drive improvements
• Develop team members to meet the needs of the organization and customers and to better understand core competencies
• May 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 Required
Experience in Quality management in the medical device or pharmaceutical industry Preferred

Additional Skills:

• Ability to manage effectively in laboratory management, including compliance, technical excellence, and organizational development required
• Proven successful project management 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
• Extensive understanding of quality laboratory and technical procedures while defining team operating standards
• Extensive understanding of related aspects of quality laboratory processes and/or systems
• Extensive knowledge of FDA Quality System Regulations, Good Laboratory Practices (GLP) and ISO/EN standards
• Basic financial acumen as it relates to quality laboratories
• Demonstrated skill set to manage small team 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 integrate metrics into the projects and operations
• Ability to influence cross-functional partners
• 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
• Primarily interacts with internal subordinates and other supervisors
• Typically interacts with external suppliers, vendors and/or customers
• Share information and provides basic problem solving solutions; gains cooperation of others, conducts presentations of technical information concerning specific projects or schedules
• 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.
• 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

Edwards Lifesciences