Global Quality VP in Sunnyvale, California at Cepheid

Date Posted: 7/9/2019

Job Snapshot

Job Description

Job ID: CEP003506

About Us

At Cepheid, we are passionate about improving healthcare through faster, more accurate diagnostic tests. With our GeneXpert® System, we’ve taken the most sophisticated molecular technology and packaged it into an automated, easy-to-use format that has quickly become the platform of choice worldwide. From the largest laboratories to small physician offices, our game-changing solution delivers critical answers when clinicians and patients need them most. Through strong molecular biology capabilities and ongoing product innovation, we are focused on developing tests for healthcare-associated infections, sexual health, critical infectious disease, virology, and oncology applications. Come join our vision for a better way and help make life better for us all! For more details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).


Description

Job Description:
The VP Global Quality is based in Sunnyvale CA responsible for strategic & operational leadership for Quality Management and Quality Operations of Cepheid global sites.

This position will set the strategy for global quality operations; lead the overall quality aspects from product design to realization plus post market surveillance, including quality system, regulatory compliance, quality assurance, quality engineering, quality control, supplier quality and new product development (NPD) quality assurance including HW, SW and system design control as well as sustaining programs addressing products and processes across multiple manufacturing sites globally. The VP Global Quality oversees Quality system and Quality operations including reagent, consumable and instrument manufacturing, contract manufacturing, supplier quality management to meet US FDA and ISO13485 requirements by partnering with peers, customers and functional department leaders. The VP Global Quality role reports to Senior Vice President Quality Regulatory and Clinical Affairs of Cepheid. The VP Global Quality will support the vision of Senior Vice President Quality Regulatory and Clinical Affairs (QRC) to execute the overall QRC strategies set for Cepheid

Responsibilities:
•Build and develop a high performing quality assurance team.
•Directs and oversees the quality planning processes; participates in strategic and tactical planning processes.
•Build interface with Research and Development, Clinical Affairs, Regulatory Affairs, Operations and Commercial operations to assure that NPD quality meeting pre-launch, production and post launch requirements
•Collaborates across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively.
•Communicates and reports regularly to executive management, users and staff on the status of the quality system.
•Utilize Danaher Business System (DBS) tools to drive compliance and effective processes
•Assure that there are no significant interruptions to the business due to quality or compliance issues
•Develops resourcing strategies, allocates budgets, staff, tools and specialized support necessary for efficient operations
•Lead employee development, communication and training programs in connection with the company's strategic goals, quality objectives, and operational systems.

Job Requirements



Qualifications

Required Knowledge, Skills, and Abilities:

•Bachelor's Degree in engineering, biology, chemistry, or related field; Master or Ph.D. degree preferred
•Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
•Minimum 20 years of experience in In Vitro Diagnostics, quality engineering and /or quality systems in FDA regulated industry
•Medical Device industry experience, preferably IVD
•Expert knowledge of US FDA, ISO and key global regulatory requirements
•Minimum 10 years of department lead experience in managing both processes and resources
•Exceptionally strong team player with excellent interpersonal and communication skills, and experience in coaching and developing people
•Extremely detail-oriented with strong organizational skills and high quality standards
•Excellent written and verbal communication skills
•Develop strategic goals and objectives from knowledge base and understanding of a customer’s business.
•Manage changing conditions, processes and approaches; lead organizations through change effectively.
•Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals.


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.