Supervisor, Validation

Genalyte•San Diego, CA

32d•$85,000 - $100,000

About The Position

At Genalyte, we're revolutionizing diagnostic testing to empower a healthier future. Genalyte is a San Diego-based diagnostics company developing the Merlin platform, an automated decentralized lab featuring our novel photonic ring resonator-based system designed to deliver rapid, multiplexed diagnostic results. We believe that timely and accurate health insights shouldn't be a luxury, but a necessity. We are driven by a vision where advanced diagnostic capabilities are accessible, efficient, and seamlessly integrated into healthcare. Genalyte is more than just a laboratory; we are advocates for health empowerment, dedicated to providing insights that can transform lives and communities. The Supervisor, Clinical and Systems V&V is responsible for overseeing Research Scientists and Phlebotomists in day to day activities in the Phlebotomy and Validation team. The Supervisor will take a supportive role in activities relating to method feasibility, verification, validation, and transfer including oversight of change controls, protocol/Work Instruction generation, sample preparation and data evaluations. This position will work closely with the various product development teams to coordinate V&V activities and ensure planning activities are completed prior to initiation of V&V studies. As manager within the Clinical Affairs team, they will execute clinical studies in accordance with IVD clinical guidelines, applicable regulatory requirements, company SOPs, and study protocols. They will participate in the management of budgets and timelines, as well as all the tasks of clinical study and ongoing process of improvement of clinical standard operation procedures, work instructions and tools. A Manager of Clinical Affairs works for all the IVD product lines, including Immunoassay, Hematology and Clinical Chemistry. The Supervisor will interact with Project Managers, Assay Development, Quality and Regulatory to address problems, identify solutions, resolve timelines issues, and communicate conflicting project goals. Works with Manufacturing to set up and optimize production, communicate product manufacturing strategies, new processes, and new competency requirements. Works within our team to optimize downstream testing and to streamline with clinical as appropriate. Provides updates to Management and to Project Teams, when participating in cross-functional teams. Ensures all issues related to the success of the product launch are communicated to the Manager Quality Assurance.

Requirements

Bachelor’s Degree in Engineering, Science, related field or equivalent
2+ years of relevant experience in a pharmaceutical or medical device environment. ISO13485, ISO 62304 and FDA QSR experience.
Experience in development and implementation of standards, procedures, and guidelines in support of validated operational processes.
Ability to clearly articulate design verification and validation process concepts to the business community through written and oral presentations.
Strong analytical and problem-solving skills
Good organizational skills, and the ability to manage multiple tasks
Experience in product development and experimental design
Ability to work within cross functional teams
Strong communication skills, written and verbal
Must exhibit professionalism, confidence, maturity, a desire to succeed, proactivity, and self-motivation
Strong knowledge of relevant analytical tools
Ability to participate in planning and managing projects
Working knowledge of product development tools and processes (e.g. Design Input, Design Output, Verification and Validation, Product Risk Management)
Knowledge of related quality systems regulations and processes
Appropriate computer skills (e-mail, word processing, statistical, spreadsheet software)
Ability to successfully complete projects while maintaining empathy for the team
Persuasive, encouraging, and motivating
Excellent negotiation and conflict resolution skills
Flexible during times of change
Ability to work in a startup-like culture and conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities
Ability to understand and flex to different communication styles of team members and contractors who come from a broad spectrum of disciplines
Ability to elicit cooperation from a wide variety of sources, including upper management, clients, and other departments
Ability to apply V&V expertise in the development and implementation of functional strategies to support corporate goals and objectives

Responsibilities

Oversee laboratory inventory management
Actively participates on design teams, understands project goals and timelines, and provides leadership to ensure product launch success
Actively communicates project status, challenges, concerns, and resource constraints to area management
Writes design control documentation and executes/oversees associated test and risk management activities
Maintains project documentation in accordance with internal Genalyte and external regulatory requirements as part of the design control process
Provides guidance to V&V, R&D or other functions as needed
Carries out duties in compliance with established business practices and policies
Provides support and guidance for troubleshooting method issues
Resolves complex technical problems through teamwork, communication, and application of technical expertise
Supports improvement verifications, validations, and transfers
Develops, reviews, or approves execution protocols and group generated data
Oversee studies, reviews protocol execution, and approves summary reports
Effectively communicates with support groups across the company
Maintains high levels of communication with other laboratory teams to support the coordination of shared resources
Performs evaluations and action-item assignments related to change controls
Reviews and approves document changes for SOPs and other technical documents
Ensures group members have and use appropriate engineering controls, safety procedures and PPE. Encourages a strong culture of team and individual safety awareness and accountability
Coordinates cross-functionally across the site to support project planning and execution
Ensures an appropriate and effective level of understanding of project needs to appropriately schedule and complete activities as committed
Performs analysis and determines appropriate actions in investigations, deviations, CAPAs, and continuous improvement to ensure compliance with all GMP requirements
Anticipates and troubleshoots issues regarding processes, procedures, and documentation
Utilizes scientifically sound, risk-based approaches to determine the impact and root cause of issues as they are identified
Develops and implements corrective actions
Leads and develops best practices
Independently supports the assay V&V vision on the project teams
Performs other tasks as assigned.