Job Information
Edwards Lifesciences Senior Manager, Quality Laboratory in Irvine, California
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.
How You Will Make Impact:
Manage and/or oversee the work of assigned team within a site laboratory (e.g., Microbiology, Chemistry) including responsibilities on on-going projects within manufacturing in collaboration with key stakeholders, oversee qualification of lab equipment, department budget, the development and validation of laboratory test methods in support of production and/or new product/process development. Overall leadership in ensuring Lab processes/personnel complies with pertinent Laboratory Environmental and Safety regulations.
Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope and objectives. Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups
Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards and guidelines
Develop a robust talent development plan in alignment with functional growth strategies of the department including meeting the needs of the organization and customers and to better understand core competencies
Lead in the development, monitoring and publishing of appropriate metrics for the organizationIdentify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external stakeholders. Develop strategies and address trends and issues within own area including risk management
May actively participate in the EW Global Laboratory council to help drive consistency and improvement and lead initiatives across laboratory network
Other incidental duties: Participate in cross-functional workstreams leading to continuous improvement (e.g., Lean Six Sigma). Facilitate team to ensure laboratory specific investigations are performed in compliance with quality and regulatory requirements.
What You'll Need (Required):
Bachelor's Degree in in related scientific field (e.g., chemistry, biology or microbiology) related experience within applicable regulated laboratory Required and
Experience in Quality management in the medical device, pharmaceutical industry, or the equivalent Required and
Demonstrated track record in effective laboratory management, including compliance, technical excellence, and organizational development Required
What Else We Look For (Preferred):
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 addressing issues with impact beyond own team based on knowledge of related disciplines
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 subordinate production supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team
Participate and present at meetings with internal and external representatives
Resolve operational and scheduling issues
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.
Develop relationships and leverage them to influence change
Support and solicit input from team members at all levels within the organization
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, the base pay range for this position is $133,000 to $187,000(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 complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.
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.