Senior Director Quality AssuranceApply Job ID 2017-5032 Category Laboratory Operations Job Location Redwood City, CA Posted Date 07/26/2017
The Senior Director, Quality Assurance has primary accountability for the development and continuous improvement of Genomic Health’s Quality System to ensure that these procedures, policies, processes, and systems meet the needs of the company’s global business. These needs include regulatory compliance, effective quality management, operational scalability, and the flexibility required by our rapidly growing worldwide business. The QA leader must be results-driven and team-oriented with an enthusiastic attitude, strong leadership, broad perspective, deep expertise in quality systems, excellent interpersonal skills, and the ability to influence outcomes in a changing regulatory environment. The Senior Director, Quality Assurance maximizes the effectiveness of our Quality System through direct management of Genomic Health QA resources and through effective collaboration and influence with company executives, functional area leaders, and key subject matter experts throughout the organization, including Operations, R&D, IT, Commercial, and other areas.
The ideal candidate will have experience including medical device, in vitro diagnostics, and clinical laboratory regulations, quality systems, and best practices, extensive management experience, and a successful track record in development and ongoing improvement of Quality Systems in a highly dynamic environment.
- Lead the strategic development, implementation, application, and continuous improvement of Genomic Health’s Quality System meeting both operational quality and regulatory requirements for our global business, with an initial focus on the US, EU, Canada, and Japan
- Lead Genomic Health’s Corporate Quality Assurance function, with direct management responsibility for the staff and accountability for ensuring that this team has the technical and professional skills, organizational structure, capacity, and business processes in place to maximize the value of Genomic Health’s Quality System
- Facilitate effective cross-functional communication, alignment, collaboration, leadership and execution on quality-related objectives, plans, and priorities
- Keep abreast of the evolving regulatory policy and industry best practices related to Laboratory Developed Tests and In Vitro Diagnostics in the US and internationally, leading the evolution of our Quality System as appropriate to adapt to these
- Develop business cases for proposed investments and changes in systems, processes, staffing, and organizational development for Quality Assurance, providing clarity on costs, benefits, alternatives, resource requirements, and other relevant information to enable timely, effective decision making
- Provide expert advice to executives and functional area managers on QA related issues, including those with company-wide or external impact
- Collaborate with functional areas to establish and update metrics that are reported to upper management that highlights risks and key opportunities for continuous quality improvement
- Provide QA input to manufacturing, Quality Control, and product development processes to maintain compliance with the relevant quality regulations and international standards
- Provide QA input and resources to author, review and finalize quality-related documents for regulatory submissions globally, including PMA, 510(k), and CE-IVD
- Host FDA/third party regulatory audits (including pre-approval inspections for PMAs), and ensure follow up on findings/observations issued including issuing CAPAs as needed
- Serve as Genomic Health’s Quality Management Representative to FDA, other regulatory bodies, and ISO auditors
- Lead Quality System Management Review meetings, in accordance with regulations and internal procedures
- Identify and suggest functional improvements to the Document Control and Quality Assurance organizations to further ensure regulatory compliance and constant inspection readiness
- Ensure Quality representation on Product Development Design teams.
- Ensure that budgets, schedules, and department performance requirements are met
- Other duties as assigned
- Bachelors degree in chemistry, biology, engineering or related field
- Minimum 8 years of experience in a QA leadership and management role (e.g. Director, Senior Director) in medical device / IVD field, with direct management responsibility for QA personnel and responsibility for a broad spectrum of Quality System elements
- Demonstrated success leading cross-functional development, implementation, application, and maintenance of Quality Systems which comply with FDA QSR, GCP, GLP, and related US and international regulations and ISO standards pertaining to IVD development and ongoing commercial manufacturing and delivery Successful track record of selecting, implementing, and optimizing electronic quality management system software including modules for document control, complaints, nonconformances, CAPA, and other Quality System functions
- Successful track record leading FDA and ISO inspections and internal quality audits
- Exceptionally strong team leader and team player with excellent interpersonal and communication skills, and experience working with end-users in a coaching capacity
- Extremely detail-oriented with strong organizational skills and high quality standards
- Outstanding written communication skills with experience in authoring both internal and externally facing quality related documents
- Superb interpersonal and verbal communication skills, with the ability to effectively communicate with employees, functional area and executive management, customers, and business partners
- Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, an enthusiastic, optimistic outlook, and a collaborative style
- Ability to integrate and apply feedback in a professional manner
- Experience with molecular diagnostic assays is strongly preferred
- Working knowledge and experience with Clinical Laboratories, Laboratory Developed Tests, and the relevant regulatory requirements and quality standards (e.g. CLIA, CAP, NY, EU IVDD, and ISO 15189) is highly desirable
- Previous experience in other functional areas (R&D, Quality Control, Operations), in addition to QA experience is a plus
Travel, Physical/Mental Demands and Work Environment:
Genomic Health is a global provider of genomic-based diagnostic tests that address the overtreatment of cancer, one of the greatest issues in healthcare today. Our goal is to improve the lives of people with cancer by providing personalized, biological information that helps them get the right treatment at the right time, and to avoid unnecessary treatments and their side effects. In this way, our work is truly life, changing.
- Our Oncotype IQ Genomic Intelligence Platform is a portfolio of diagnostic tests that help physicians and patients answer specific and critical treatment questions throughout the cancer journey
- We currently offer Oncotype tests addressing breast, colon, prostate and lung cancers and hundreds of thousands of patients from over 90 countries have benefited from our tests.
- The Oncotype DX breast cancer test is considered standard of care in the US and is included in all major international clinical guidelines for breast cancer treatment.
- We are expanding our portfolio of tests to include additional liquid- and tissue-based tests through clinical research and internal product development as well as strategic partnerships.
Join the Genomic Health Team, and have the unique opportunity to make a difference in the lives of patients with cancer, while developing your career potential. We embrace our unique culture characterized by our Core Values of Community, Truth Seeking, Being Ahead of the Curve and Winning to be the best in the world at what we do. We maintain competitive total rewards programs designed to satisfy our employees’ work life and personal life needs.
All qualified applicants will receive consideration for employment without regard to race, sex, gender identity, color, religion, national origin, protected veteran status, or on the basis of disability.
If you want to be part of a team that prides itself in teamwork and developing cutting-edge technology at Genomic Health, apply today!