QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

As we continue to grow as QuidelOrtho, we are looking for a Verification and Validation (V&V) Lead who will be responsible for providing oversight and guidance in the support of activities relating to method feasibility, validation, verification, and transfer including oversight of change controls, protocol generation, sample preparation and data evaluations. Responsibilities also include providing Assay V&V support for new products, assay integration, technology transfer and other assay V&V activities associated with new product development, manufacturing, and marketing.

This is an onsite role in San Diego, CA.

• Actively participates on study design , 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 such as SOPs, Best Practices, Work Instructions, etc. and executes/oversees associated test and risk management activities

• Works with other departments to develop, optimize, and integrate assay V&V of products

• Maintains project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process

• 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, application of technical expertise, and escalation to management

• Supports improvement verifications, validations, and transfers

• Develops, reviews, or approves execution protocols

• 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

• Approves group generated data

• Performs evaluations and action-item assignments related to timeline and product evolution

• Reviews and approves document changes for SOPs and other technical documents

• Mentors associates on appropriate documentation.

• 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

• Mentors group members for ongoing continued growth in technical troubleshooting using effective scientific methods

• Performs other tasks as assigned by the Supervisor, Manager and/or Director.

• BS/BA degree in a Science Field with industry experience in QC or Assay V&V preferred with a minimum of 2+ years of experience as a Team Lead or Technical Lead.

• Ability to translate priorities effectively and efficiently into design, testing, documentation, and project objectives.

• 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, Risk mitigation)

• Knowledge of related quality systems regulations and processes

• Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)

• 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 collaborators who come from a broad spectrum of disciplines

• Ability to elicit cooperation from a wide variety of sources, including upper management, colleagues, and other departments

• Ability to apply V&V expertise in the development and implementation of functional strategies to support corporate goals and objectives.

Assay V&V Manager, R&D, Clinical and Regulatory, Biostats, and QA to address problems, identify solutions, resolve timelines issues, and communicate conflicting project goals. Works with Manufacturing and PMO to set up to coordinate validation lots of devices and consumables. 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.

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $53,600 to $98,000. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com

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