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

As we continue to grow as QuidelOrtho, we are seeking a Director of Quality Operations to support our Global Quality and Compliance team. This position is responsible for proving leadership for the Site Quality Operations Organization focused on ensuring the release of high-quality products from the manufacturing facility, while maintaining compliance with the QuidelOrtho Quality Management System, and applicable policies, international law and guidance.

The scope of the role includes but is not limited to Raw Material / Component release, Quality & Validation Engineering, Final Product Release and Site Compliance & Inspection Readiness. The role is responsible for developing both short-term tactical goals and objectives in addition to longer term strategies to drive efficiencies through simplification of Quality processes and procedures while driving continuous improvement in manufacturing quality, product quality and compliance performance. The position is accountable for compliance performance at the site and is expected to host both internal and external regulatory inspections supported by the Global Compliance organization. They will collaborate with other members of the Global Quality & Compliance organization and will lead teams on the identification and standardization of best practices to drive both compliance excellence and process efficiency.

This position will be full-time onsite at our San Diego facility (Summers Ridge Campus).

The Responsibilities

• Leadership of the Site Quality organization ensuring efficient and flawless execution against the Quality System and associated processes to ensure Product Quality and Compliance with QuidelOrtho global policies, international law and guidance.
• Builds overall organizational capability and capacity to meet both the current and future needs of the business through talent acquisition, employee training / development and performance management.
• Directs activities to ensure that the site is in a continued state of compliance and inspection readiness including analysis and evaluation of data and presentation to senior management to ensure that resources are sufficient, and projects are appropriately prioritized in alignment with regulatory requirements and business goals.
• Accountable as the host for any external regulatory inspection associated with their specific site.
• Acts with delegated authority as the deputy management representative for a specific manufacturing site, to ensure quality management processes are implemented, awareness of regulatory requirements is promoted, and the effectiveness of the Quality Management System is reviewed by QuidelOrtho management.
• Responsible for Regulatory Compliance (PRRC per EU IVDR (2017/746) Article 15(3)(a): Responsible for ensuring that the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released, as applicable.
• Oversees day to day Quality Operations activities at the Site as required to support Operations including Raw Material & Component Release, Maintenance of the Site Master Validation Plan, Quality Engineering with oversight for Root Cause Investigation, Product Disposition, Corrective & Preventative Action, Microbiology and Environmental Monitoring (as applicable) and final Product Release. Collaborates with Operations and Supply Chain leaders to identify potential areas of process and product variability, addresses root causes and implements improvements through the CAPA process to ensure the flow of quality products through the supply chain.
• Utilizes data to assess the overall health and effectiveness of the Quality processes / systems and identification of areas for process improvement. Leads strategy development at the site level and supports at the global level execution of a pipeline of continuous improvement initiatives to drive simplification, reliability and overall effectiveness of Quality processes.
• Responsible for Annual Operating Plan (AOP) development and overall budgetary oversight for the Site Quality Operations organization. Partners with Finance and Operations business partners to ensure that expenses, headcount and capital are in alignment with QuidelOrtho business goals, financial targets and strategic plans.
• Holds responsibility for the Quality issue escalation process as chair of the site quality escalation process and holds decision authority for further escalation to the Global Quality Escalation Forum chairs by the Global Head of Quality & Compliance.
• Actively participates in Global Quality & Compliance Leadership forums and provides leadership, coaching and mentoring to the broader Quality & Compliance organization.
• Partners closely with the Operations organization in the development of business strategies, goals and initiatives.
• Effectively negotiates and influences senior management, regulatory agencies and peers in the industry to ensure compliance with regulatory and business needs.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's degree in Science, Engineering, QA, or other related business field required.
• Post graduate degree (MA, MS, MBA of PhD) is preferred.
• A minimum of 8-10 years' experience in the Pharmaceutical, Medical Device or Biotech Industry with a strong preference for leadership experience in a functional Quality role.
• Broad based technical knowledge and skills in diverse areas of business such as Quality Engineering, Quality Assurance, Quality Systems, GMP Operations as well as a good working knowledge of related functions such as operations, supplier management, laboratory operations and product development.
• Possesses strong conflict resolution, change management, communication (written and verbal), organizational management, business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional environment,
• Working knowledge of both FDA CDRH and CBER (licensed biologics) Quality Systems Regulations (where applicable), CMDR and ISO13485 standards.
• Ability to host / manage external Quality System inspections is required with a preference for experience gained with hosting CDRH (FDA) and other health authority inspections.
• Must be able to collaborate with and influence external regulatory agency personnel, and other external business partners including Raw Material / Component suppliers.
• Demonstrated knowledge of business impact of compliance issues and risk management is required. Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is a prerequisite. Expert knowledge of Good Manufacturing Practices, all applicable.
• Regulations and validation methods is necessary.
• Estimated travel 5% domestic.

Preferred:

• Black Belt in Lean or Six Sigma

The Key Working Relationships

Internal Partners:

• Strong working relationships with Operations, Supply Chain, R&D, Regulatory Affairs and the broader Global Quality & Compliance organization are necessary to drive effective prioritization and collaboration to meet the needs of the business.
• Close collaboration with the other functions including Product Quality, Compliance and Quality Systems, Regional QRC and other Site Quality Operations teams.
• Leaders and teams from the within the Global Operations and Supply Chain organizations.

External Partners:

• Vendors and/or customers.

The Work Environment

No strenuous physical activity, though occasional light lifting of files and related materials is required. 80% of time in meetings, working with team, or talking on the phone, 20% of the time at the desk on computer, doing analytical work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position may require the use of Personal Protective Equipment as posted.

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 $135,700 to $250,000 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

#LI-TO1