Director, IVD Reagent Manufacturing Quality Operations # 3074
Operations, Quality Assurance
Durham, NC, USA
Posted on Friday, June 16, 2023
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. GRAIL, LLC is a wholly-owned subsidiary of Illumina, Inc. (NASDAQ:ILMN). For more information, please visit www.grail.com.
This position will draw on industry expertise and best practices to lead the Manufacturing Quality Operations organization, responsible for establishing, implementing, maintaining, and improving the Manufacturing Quality Operations elements of GRAIL’s quality management system. A key element of the Director, Manufacturing Quality Operations (MQO) role includes developing, managing, and leading the team supporting these activities. This role is responsible for directing and coordinating the global Quality Assurance activities and functions for GRAIL’s internal in vitro diagnostic (IVD) reagent, clinical trial reagent, and Laboratory Developed Test (LDT) reagent manufacturing as well as external (outsourced) specimen collection kit (SCK) manufacturing. While the focus of the Director, MQO is on GRAIL’s manufacturing and associated activities, this role will also support the clinical laboratory processes as needed with consideration for the single GRAIL quality management system. This on-site leadership position will be based out of GRAIL’s Research Triangle Park (RTP), NC facility and will also require approximately 10-15% travel to GRAIL’s facility in Menlo Park, CA. This role is not available for hybrid or remote work options.
- This position interacts with departments throughout the organization including but not limited to all-Quality, Clinical Laboratory Operations, Technical Operations, Regulatory Affairs, Compliance, Program Management, Clinical Affairs, Supply Chain, Manufacturing/QC, and Global Development and Operations. The person in this role leads by example in consistently applying critical thinking skills and demonstrating excellent judgment to independently solve broad, complex problems, proactively identifying and resolving complex challenges in alignment with strategic objectives. The Director, MQO will effectively interpret, communicate, and gain consensus for functional strategy and decisions across teams and keep senior management apprised of status and recommendations.
- Direct GRAIL’s Research Triangle Park (RTP) and Menlo Park (MPK) Manufacturing Quality Operations (MQO) teams.
- Direct and implement programs at the manufacturing and warehouse locations to comply with all applicable regulatory requirements including 21 CFR 820 and ISO 13485 to ensure products meet regulatory and customer requirements.
- Support the resolution of product quality issues for on-market products, including leading compliant and effective temporary planned deviations, NCRs and CAPA workflows.
- Ensure quality and compliance of equipment management, test method, and process validation programs.
- Ensure quality and compliance of warehouse operations including receiving, distribution, inventory management, identification, and traceability.
- Ensure the pest control program is effectively implemented and documented.
- Ensure quality and compliance of IVD labels/labeling by serving as Quality approver for new and revised label-related change control workflows.
- Ensure quality and compliance of new and design-transferred products including associated product specifications and configurations developed by Design Engineering.
- Assure lines of communication between MQO and stakeholder functions on critical quality issues that may result in product impact and/or potential business interruption.
- Develop and deploy quality strategies to achieve business objectives at the plant level while ensuring product manufacturing operations are in compliance with applicable requirements, making key decisions on product quality and regulatory compliance issues.
- Assures that manufacturing quality and performance data are comprehensively measured, trended, reported, and acted on in a timely manner to ensure compliance and support continuous improvement.
- Perform periodic audits to verify correct and consistent operations and act as SME for Quality Operations during internal and external audit / inspection.
- Responsible for post-design transfer Device Master Record/Medical Device File compliance.
- Establish and implement Acceptance Activities processes for purchased and manufactured products, including Device History Record (DHR) review for internally manufactured reagents and DHR/CoC for supplier-built specimen collection kits, and Incoming Quality Assurance (IQA) material and component inspections supporting Purchasing Controls.
- Control budget and quality costs in accordance with business objectives.
- Represent GRAIL as the RTP and Menlo Park facilities on-site Quality Operations leader. Interface with partner auditors and regulators (FDA, Notified Bodies, etc.) and other government regulatory bodies, as required.
- Effectively interact with executive level management to influence strategies and decisions.
- Partner closely with the VP of Operations and other RTP site leadership in the planning and execution of commercial deliverables and product expansion for the facility. Support the Clinical Laboratory Quality Operations team, as assigned.
- Represent Quality Operations on sanctioned cross-functional projects driving toward effective, on-time completion of business goals and objectives.
- Drive a culture of quality across the organization with the goals of efficiency, compliance, and continual improvement.
- Nurture an environment that is inclusive and diverse allowing employees to be their authentic selves, while motivating them to produce their best work.
- Hire, manage, develop, coach, and mentor staff including setting individual and team goals and conducting performance reviews. Hold staff accountable for high quality performance including procedural compliance and delivery of work requiring minimal rework, routinely monitoring and measuring performance and providing regular feedback.
Your background and qualification will include:
- Qualifications and experience (Required):
- BS/BA degree + 12 years of related experience, or Masters + 10 years of related experience, or PhD + 8 years of related experience within a medical device, pharmaceutical, or biotech quality management system.
- Extensive previous managerial experience associated with implementation of applicable regulations and standards including but not limited to IVDR, 21 CFR 820, ISO 13485, ISO 14971, and 21 CFR 11.
- Proven leadership, organizational and management skills to effectively lead cross-functional decision making.
- Experience preparing for, leading, and supporting regulatory inspections/audits and effectively responding to findings.
- Must be articulate and able to communicate effectively verbally and in writing, across the organization.
- Ability to comprehend and interpret technical information related to manufacturing and associated processes and applicable regulatory requirements.
- Qualifications and experience (Preferred): Master’s degree in a related technical area, or MBA.
- Next Generation Sequencing (NGS) experience.
- Clinical laboratory QMS experience including ISO 15189, 21 CFR Part 493 (CLIA), CAP, New York State Department of Health (NYSDOH). ASQ Certified Quality Auditor, Certified Quality Engineer, or similar.
Based on the role, colleagues may be eligible to participate in an annual bonus plan tied to company and individual performance, or an incentive plan. We also offer a long-term incentive plan to align company and colleague success over time.
In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
GRAIL is an Equal Employment Office and Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. We will reasonably accommodate all individuals with disabilities so that they can participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. GRAIL maintains a drug-free workplace.