Associate Director, Assay V&V

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.

The Role

QuidelOrtho is hiring an Associate Director supporting Assay V&V.

The Associate Director, Assay V&V plays a crucial role in the management, planning, resourcing and execution of verification and validation activities across various assays on multiple platforms. The Manager also provides oversight and guidance to the Assay V&V Team. The position is responsible for verification and validation of new Assays and consumables, across all platforms as well as requirements reviews, verification and validation/test planning, study execution and reporting.

The Associate Director, Assay V&V works with multiple groups, including Project Management, Research and Development, Quality, Regulatory, Marketing, and various other business departments. This person defines the goals and objectives of the Assay V&V Department by developing and managing plans, protocols, data, and reports as they relate to Assay V&V efforts. The Associate Director, Assay V&V ensures that the assay verification and validation processes are understood and appropriately used during implementation and issues are escalated/resolved in a timely manner. In addition, the Associate Director, Assay V&V reviews processes for quality improvements, ensures that identified improvement initiatives are completed and leads all analytical verification and validation activities related to Regulatory submissions.

This position will be onsite full-time based in San Diego, CA (Summers Ridge).

The Responsibilities

• Manages the creation of verification and validation processes and documentation for assay and consumable changes and executes associated testing
• Manages preparation of verification and validation protocols and reports
• Directs creation of verification documentation for multiple assay platforms and executes associated testing.
• Directs preparation of verification reports
• Generates design verification and validation plans
• Contributes to Assay and component risk management deliverables
• Ensures that post-launch design control documentation conforms to internal procedures and medical device regulations and standards as part of ECO processing
• Manages overall assay verification including documentation of all products both under development and released
• Trains, develops, and coaches staff to continuously improve their knowledge, productivity and effectiveness in assay and consumable verification and validation activities
• Provides cross-functional support as needed to address Quidel Assay queries or complaints from the field
• Works with R&D personnel to evaluate new technologies and improvements to existing technologies as used within Quidel Assay products
• Authors and manages the execution of Validation protocols to ensure compliance and adherence with corporate policies, procedures, guidelines, and compliance regulations
• Authors summary reports for executed verification protocols
• Guides testing and compliance efforts to ensure regulatory, quality, and safety priorities are adequately addressed.
• Participates in requirements gathering for user, functional, and system requirements.
• Maintains oversight of the user, functional, and system requirements to meet the testing objectives while managing a traceability matrix to verify all testing is conducted and properly documented.
• Supports V&V approaches and requirements during audits
• Maintains a safe working environment based on established procedures
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's Degree in Engineering, Science, related field or equivalent
• 10+ years of relevant experience in a medical device environment. ISO13485, ISO 62304 and FDA QSR experience. Typically, 5 years of management experience with a V&V Group or a combination of project management, V&V and R&D experience.
• In depth knowledge of FDA guidelines relevant to 21 CFR Part 11 compliance requirements including 510(k) and PMA submissions.
• Ability to translate compliance 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.
• Knowledge of FDA design control requirements.
• Ability to clearly articulate design verification and validation process concepts to the business community through written and oral presentations.
• Good organizational skills, and the ability to manage multiple tasks
• In depth knowledge of product development tools and processes (e.g., Design Input, Design Output, Verification and Validation, Product Risk Management, Change Control)
• Strong analytical and problem-solving skills
• Knowledge of related quality systems regulations and processes
• Ability to work within cross-functional teams
• Strong communication skills, written and verbal
• Must exhibit professionalism, confidence, maturity, desire to succeed, proactive and self- motivated\
• Minimal travel 5%
• This position is not currently eligible for visa sponsorship.

Preferred:

• Experience implementing or managing post-launch design changes to Assays across all platforms
• Experience in software product development and test
• Appropriate office computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)

The Key Working Relationships

Internal Partners:

• Department associates, Assay Development/R&D, Clinical/Regulatory and project development teams to identify and verify and validate changes to new and on-market Assays across all platforms to support release or menu addition
• Clinical / regulatory as appropriate regarding Assay configurations to support clinical trials and regulatory submissions

External Partners:

• External contract developers to review and provide feedback on design changes and documentation and identify and resolve anomalies identified during V&V activities

The Work Environment

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

Salary Transparency

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 $145,000 to $180,000 and is bonus eligible. 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.

Equal Opportunity

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 recruiting@quidelortho.com.