Quality Site Head (Associate Director) - IVD

Employer
GRAIL, Inc.
Location
Raleigh-Durham, NC, United States
Posted
Feb 14, 2021
Ref
225253054
Hotbed
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. It is supported by leading global investors and pharmaceutical, technology, and healthcare companies. For more information, please visit www.grail.com.

The Associate Director, Quality will build and manage the Site QA department and collaborate cross-functionally with Manufacturing, Supply Chain, Facilities & Engineering, Clinical Laboratory, Research & Development to ensure Quality systems compliance and establish a quality culture. This position is ultimately responsible for management and implementation of the quality management system and ensuring quality standards are upheld across the organization.

You Will:

• Help define, communicate, and drive the Quality vision and mindset of the entire site in close collaboration with the Quality Leadership Team
• Be responsible for the overall quality oversight and compliance systems at the North Carolina site in coordination with corporate quality processes and personnel
• Build and implement quality systems for the site; ensuring rollout and connection to corporate global systems and processes
• Build and implement a quality validation team which will oversee the overall CQV (Commissioning, Qualification, and Validation) effort of the various startup phases of the facility build
• Establish a quality control organization that will leverage both internal and external contract capabilities to enable the QC testing needs for the facility and programs
• Establish a QA compliance organization for the site to ensure GMP and GLP compliance in manufacturing and testing, exception management, and overall material lot review and disposition
• Work and coordinate with other members of the greater quality organization (outside of the NC organization) to assist in developing, implementing, refining, and providing input to the overall Quality Management System (QMS) growth and evolution over time
• Lead the functional and site goals and objectives
• Establish and own the implementation of quality metrics for the site and ensure that a management review process is in place
• Represent as the overall face of quality for the site for audits and inspections by clients, FDA, and other regulatory agencies
• Create and manage the NC Site Master File
• Collaborate with operations to provide both strategic and tactical Quality decisions regarding innovative technologies, industry best practices, new regulations, and processes in end-to-end supply chain operations
• Ensure appropriate escalation and solution of significant issues that may impact patient safety, product quality, supply, regulatory compliance or the company brand image
• Support due diligence audits, site selection, and qualification of external partners as necessary
• Define clear Quality objectives and ensure progress and cross-functional completion of responsibilities; use judgment to develop solutions and drive risk analysis and mitigation strategies
• Provide leadership, guidance, and direction to staff consistent with cGxP
• Support other members of the Quality Team and organization during its growth period in aspects related to the core responsibilities of the Quality Systems

Your Experience Will Include:

• A BS in Biological Science or related technical field
• 15+ years of related experience in the Quality Unit
• Experience leading teams associated with elements of Quality and Quality Control/Analytical as part of overall background is preferred
• 8+ years of Quality management experience
• Excellent verbal and written communication skills, detail-oriented personality and ability to work and drive change across functions
• Experience interacting with regulatory health authorities at pre- and post-approval inspection

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does not accept any liability for fees for resumes from recruiters or employment agencies ("Agency"), without a binding, written recruitment agreement between GRAIL and Agency describing the services and specific job openings ("Agreement"). GRAIL may consider any candidate for whom an Agency has submitted an unsolicited resume and explicitly reserves the right to hire those candidate(s) without any financial obligation to the Agency, unless an Agreement is in place. Any email or verbal contacts with any person within GRAIL is inadequate to create a binding agreement. Agencies without an Agreement are requested not to contact any hiring managers of GRAIL with recruiting inquiries or resumes. Agencies interested in partnering with GRAIL may contact GRAIL's HR Department through our Customer Service team .