Director of Global Supply Network Excellence

The Opportunity

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 6000 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 one QuidelOrtho we are seeking a Director of Global Supply Network Excellence. The Quality & Compliance Director is a global people leader within QuidelOrtho s Global Quality & Compliance (GQ&C) organization. This leader is responsible for developing and leading a team of Quality professionals to ensure the design implementation and continuous improvement of Quality systems processes and programs that enable QuidelOrtho s Right to Operate and support business agility innovation and growth. This role provides strategic direction and operational oversight across QuidelOrtho s overall supply network providing leadership for supplier quality and supply chain quality ensuring alignment with global regulatory requirements (ISO 13485 FDA 21 CFR 820 IVDR and other applicable standards). The role partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle driving harmonization inspection readiness and continuous improvement. The role leads the strategy for quality support of end-to-end supply chain. Encompassing distribution marketing companies and supplier management. The responsibilities span all quality elements associated with the supplier management process including initial partner selection creation and maintenance of quality agreements monitoring of overall partner organization quality performance supplier audit change management and non-conformance / CAPA oversight. This position includes the oversight of the purchasing control processes. This role also demands identification and execution of continuous improvements to QuidelOrtho s Supplier Quality Management processes at the global level to meet the current and future needs of the QuidelOrtho business. These improvements will ensure continued compliance with quality system regulations while driving overall efficiencies and improvements in QuidelOrtho s Supplier Quality Management Processes. These initiatives will demand close collaboration with key stakeholders and business partners across the organization including but not limited to Global Procurement Global Supply Chain Operations R&D Site Quality Design Quality Global Compliance and Regulatory. This leader is also accountable for developing talent strengthening scientific and compliance capabilities and fostering a culture of engagement collaboration and performance. By integrating technical expertise data-driven insights and agile leadership behaviors the Quality & Compliance Manager/Senior Manager ensures that Quality systems and teams deliver sustainable business and compliance outcomes.

This position will be onsite in Rochester NY or San Diego CA.

The Responsibilities

• Lead develop and inspire a team of Quality professionals to achieve organizational and individual performance objectives.

• Establish clear priorities assign responsibilities and ensure effective resource allocation to meet business and compliance needs.

• Provide technical regulatory and operational leadership to ensure Quality systems comply with ISO 13485 FDA 21 CFR 820 IVDR and other applicable requirements.

• Management Responsibility as required by ISO13485/9001 and ensuring specific economic operator roles are fulfilled for example importer / distributor / Authorized Representative responsibilities

• Drive harmonization and standardization of Quality processes procedures and tools across sites and functions to strengthen compliance and efficiency.

• Partner with Manufacturing R&D Regulatory Affairs Supply Chain and other stakeholders to integrate Quality and Compliance principles throughout the product lifecycle.

• Promote a culture of continuous improvement by identifying opportunities for simplification process excellence and digital enablement within the Quality Management System (QMS).

• Ensure the team maintains a state of inspection readiness and supports successful engagement with regulatory agencies notified bodies and internal audits.

• Monitor Quality performance using metrics and data analytics to identify risks drive root cause analysis and implement sustainable improvements.

• Coach and mentor emerging Quality leaders and technical experts to build organizational capability and ensure robust succession planning.

• Communicate Quality and Compliance strategy progress and risk mitigation plans to senior leadership and cross-functional stakeholders.

• Manage departmental budget and resources effectively identifying opportunities to drive cost efficiencies while maintaining compliance and quality standards.

• Model QuidelOrtho s leadership principles by demonstrating collaboration accountability inclusion and service mindset in all interactions.

• Person Responsible for Regulatory Compliance (PRRC per EU IVDR (2017/746) on behalf of the wholly-owned legal manufacturers of QuidelOrtho Corporation as defined in the Delegation of Authority (DMS-POL80064)

• 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.

• Execution of Importer and distributor responsibilities specially making sure that the devices placed on the market bear the CE marking are accompanied by the required information and labelled in accordance with the Regulation and storage and transport conditions are in line with specifications.

• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelors degree in Life Sciences Engineering or a related technical discipline required.12 years experience in Medical Device quality system management

• Strong understanding of Quality System regulations and standards including ISO 13485 FDA 21 CFR 820 and IVDR

• Experience/knowledge of Supplier Quality Management Processes auditing Change Management Root Cause Analyses Corrective/Preventive Actions

• Experience/knowledge with distribution processes logistics and supply chain operations

• Proven ability to lead and develop high-performing teams and build future technical and people leaders.

• Demonstrated success driving Quality and Compliance initiatives that align with business strategy and regulatory expectations.

• Excellent collaboration influence and communication skills across functional and organizational boundaries.

• Strong analytical and problem-solving skills with experience using data to drive decision-making and improvement.

• Experience leading in a matrixed global organization and managing competing priorities effectively.

• Commitment to scientific integrity compliance excellence and continuous improvement

Preferred:

• Desirable certifications include ASQ CQA ASQ-CQE ASQ-SWQE ASQ-CQM

• Advanced degree (MS PhD MBA or equivalent) in a relevant discipline.

• Experience implementing or optimizing global Quality Management Systems (QMS) and digital tools.

• Lean Six Sigma PMP or similar certification demonstrating process improvement expertise.

Key Interactions

Internal: Operations Supply Chain R&D Commercial Regulatory Affairs and other Quality & Compliance teams globally and regionally

External: Suppliers/External Manufacturers: In line with established Quality Agreements ensure partnership with External Partner sites to monitor and improve quality performance

Work Environment

The work environment characteristics are representative of a manufacturing laboratory or warehouse environment.

How We Work

At QuidelOrtho our culture is shaped by four core behaviors that guide how we collaborate make decisions and support each other and those we serve. The ideal candidate will exhibit these behaviors as we believe theyre essential to how we thrive as a team and achieve meaningful impact:

• Thrive Together Collaborate intentionally grow as a team

• Make It Happen Focus on priorities embrace continuous improvement

• Commit to Service Cultivate a service mindset

• Embrace Inclusion Be open and authentic welcome diverse perspectives

Salary Transparency

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 that facts and circumstances of each case. Salary range for this position is $155000 to $249000 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 Employment 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 their 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 .

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