Supervisor, Validation

ABOUT GENALYTE 

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.

WHY WORK FOR US 

We believe in investing in our employees' well-being and success. As a valued member of our team, you'll have access to a comprehensive benefits package, including competitive salary, health, dental, and vision insurance, and generous paid time off. Additionally, we offer stock ownership and equity participation, providing you with the opportunity to directly share in the success and growth of the company. Join us in shaping the future of healthcare while building a rewarding career.

POSITION SUMMARY

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. 

ESSENTIAL FUNCTIONS & RESPONSIBILITIES

These may include but are not limited to: 

• 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. 

ADDITIONAL FUNCTIONS & RESPONSIBILITIES

Please note that this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.  Duties, responsibilities and activities may change at any time with or without notice. 

EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS AND ABILITIES

• 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. 

Knowledge/Skills 

• 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

SALARY RANGE
The base range for this role is $85,000 - $100,000 per year. Individual pay may vary based on additional factors, including but not limited to, job-related skills, experience, work location, and relevant education or training. In addition to base salary, Genalyte provides generous benefits, and equity opportunities.