Senior Director, Microbiology and Sterilization Support

Imagine how your ideas and expertise can change a patient’s life. Our Quality teams help shape the development of groundbreaking technologies to ensure each stage of our innovation process is held to the highest standards of integrity and safety. You’ll bring your passion for problem solving and partner with various teams to influence decision-making for a product’s entire lifecycle. Your work will involve you optimizing product development to impact patients around the world with pioneering technology.

How you will make an impact:

• Coordinate and assure a high level of customer service for all microbiology based testing and sterility assurance strategies for Edwards’ manufacturing.
• Develop and execute robust talent development plan in alignment with functional growth strategies of the department.
• Oversee/direct the development, implementation, and maintenance of training programs to ensure adequate training of personnel on Quality processes and documentation.
• Plan and direct strategic quality management activities including prioritizing and selecting appropriate projects with overall responsibility for meeting business objectives.  Lead in identifying risk, developing complex mitigation strategies, defining alternative solutions and resolving issues in collaboration with cross functional groups.
• Anticipate/eliminate complex quality issues and support timely resolution in collaboration with R&D, Manufacturing Engineering, Operations, Quality and other departments.
• Oversee the audit management process of external inspections (e.g. FDA, Notified Bodies, and other regulatory authorities) including timely closure of post approval commitments, responding to inspections/audit, and resolving open issues with regulatory agencies.

What you'll need (Required):

• Bachelor's Degree in in related field, 14 years related experience in a laboratory and skill levels exceeding the requirements of the previous level
• OR Master's Degree and 12 years previous related experience.
• Demonstrated track record in management of technical and/or regulated disciplines

What else we look for (Preferred):

• Proven successful project management leadership skills
• Experience working in a regulated industry
• 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
• Ability to lead a team of highly skilled scientists
• Knowledge of financial acumen as it relates to the business as well as laboratory operations
• Demonstrated ability to direct 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 engineering to the business
• Serve as core partner to senior leaders in Business Units, Functional Groups, Regions and IT
• 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
• Interacts with senior management, and others concerning matters of significance to the company
• Conduct business and technical briefings for senior and top management and for external representatives
• Regularly interacts with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior level leaders regarding matters of significance to the organization
• 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 large 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 within the organization

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.