VP, Quality

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.

The VP, Quality is a key member of the Quality Leadership Team, responsible for heading the Irvine Manufacturing Plant and Corporate Microbiology, Biology, and Chemistry laboratories.  They will lead the Global Laboratory Council working to implement best-in-class systems, methods, and procedures across the global laboratory network.

How you'll make an impact:

• Set the overall quality laboratory strategy, emerging trends and best practices while providing oversight and strategic leadership to the chemistry, biology, and microbiology laboratories located in Irvine, California and Draper, Utah.

• Drive a culture that is focused on quality and business results.  Create an environment that fosters employee motivation and engagement.

• Lead the Global Laboratory Council with a strong focus towards implementation and standardization of best-in-class systems, methods, and procedures across the global laboratory network.

• Partner with R&D, Regulatory Affairs, and Operations to support all Edwards business units with execution of related processes, client service level agreements, continuous improvement initiatives, and quality compliance objectives.

• Anticipate regulatory impacts to safety testing strategies, identify risk to product strategy and timeline, and provide recommendations/solutions for risk mitigation.

• Support external inspection/audit management.  Interface with regulatory agencies to resolve issues.

• Asses and improves laboratory systems and processes by increasing efficiency and reducing costs.

• Develop and monitors appropriate metrics for the organization to facilitate accomplishment of the tasks above.  Monitor and track projects and initiatives to assure objectives are met.

• Develop technical and managerial leadership skills in the organization and fosters technical excellence in all activities.

• Ensure that adequate resources are made available to maintain an effective quality management system.  Properly manages organizational budget.

• Act as theTest Facility Manager Designee for Irvine Biology GLP Laboratory.

• Maintain expertise in current and emerging GMP, GLP and FDA QSR requirements, quality trends, and international regulatory compliance standards.  Interpret regulations and trends; develops comprehensive quality and risk management systems to proactively address these requirements.  Recommend and execute changes to quality standards to ensure conformance.

What you'll need:

• A minimum of fifteen (15) years of experience in Quality and/or Compliance Management of a large organization in the medical device or pharmaceutical industry.  Experience in management of chemistry, biology, or microbiology laboratories.

• A bachelor's degree in a science field, engineering or quality is required.  An MS or MBA is desired.

What else we look for:

• Proven leadership skills with a record of experience and success in building and engaging a high performing team including the ability to collaborate, take initiative and work as a team leader and as a member of a team.

• Displays broad perspective and effective judgment, demonstrates well-reasoned problem solving and decision-making.  Well-developed business acumen with an understanding of the financial and market implications.

• Deemed an expert in all matters relating to global Quality Assurance and Regulatory Compliance.  Ability to take charge in a crisis and resolve quality related issues.

• Ability to lead talent in a culturally diverse, matrixed organizational structure.  Able to design and implement quality improvement processes in support of business plans, and effective in in collaboration with Business Unit and Global Supply Chain partners.

• Knowledge of US FDA Quality System Regulations, ISO 13485, ISO 14971, and other applicable global regulatory requirements.  Demonstrated success and work history of positive interactions with FDA, Notified Bodies, and other regulatory authorities.

• Ability to travel up to 25% of the time.

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 $224,000 to $318,000 (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 protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been 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 locations where it is prohibited by law to impose vaccination.