For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has over 20.000 employees in 30 countries. Grifols' three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
The Senior Manager, Verification and Validation (V&V) has accountability for ensuring Grifols Diagnostic product offerings conform to all systems, regulatory, and customer requirements. He/she is responsible for building and leading a skilled test team. This person will lead the development and execution of Systems and Software V&V, utilizing best practices in verification, validation, and problem-solving. He/she will also engage the team in support of systems engineering activities, including technical investigations, studies, and general systems engineering tasks as needed to support company efforts. Using devices and software of appropriately recorded configurations performs the required testing and analyses, and documents work to meet standards and project delivery commitments.
Primary responsibilities for role:
Accountable for ensuring accurate verification and validation of Grifols Diagnostic Solutions products
Accountable for ensuring proper resourcing (people and skills) and execution against project schedules for Verification and Validation (V&V) activities
Works closely with Systems Engineering, Project Management, Marketing, Quality and Regulatory personnel on project teams to create, develop, and commercialize products
Partner with Regulatory Affairs, Clinical Affairs and Quality Assurance, Manufacturing, and Service to provide technical support
Responsible for representing the V&V function during internal and external audits
Implements V&V strategies by defining, managing and delivering verification and validation project deliverables.
Provides oversight and guidance to project teams to create, review, execute and approve verification and validation deliverables
Project deliverables include producing and/or reviewing verification and/or validation plans, protocols, and reports; successful execution of the plans and protocols within assigned target dates; and resolving deviations
Manages project budget and timeline for verification and validation activities and provide updates to project teams.
Manages the V&V Team of full time and temporary staff including recruiting, training and mentoring Design Verification and Validation Engineers
Utilizes best practices in verification, validation and problem solving
Identifies and drives continuous improvement of SOPs related to V&V and design control for efficiency and compliance
Engage in systems engineering activities, including technical investigations, engineering studies, and general systems engineering tasks as needed to support project and business efforts
Manage a BSL-2 testing lab, including following all HSE regulations and inspections
Knowledge, Skills, and Abilities:
Capability to solve technical and management problems.
Experience with automation tools for testing applications
Familiar with engineering process improvement methodologies
Demonstrated ability to work well with diverse groups of people, as well as partnering with external vendors
Ability to drive commitment to V&V team initiatives
Capable of managing multiple tasks and priorities simultaneously and adapt to changes in program priorities.
Excellent communication and interpersonal skills
Bachelors Degree or advanced degree in a technical discipline such as Engineering (Computer, Electrical, Chemical, etc), Life Sciences or equivalent.
10+ yrs experience in design verification or validation, with a significant portion of that including software
6+ yrs experience directly managing a small team and working on cross-functional teams
6+ yrs experience with medical equipment or other equipment experience involving complex, multicomponent systems, including lab automation.
Significant experience leading product development per FDA design control and ISO 13485 required
IVD experience is desirable
Proven track record of creating and implementing successful verification and validation plans, protocols, and reports.
Hands on experience with requirements management, risk-based testing approaches, defect tracking, and configuration control tools.
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience.
Location: NORTH AMERICA : USA : CA-Emeryville:USEMV - Emeryville CA-Headquarters
Learn more about Grifols