Manager, Data AnalyticsOrtho Clinical Diagnostics • Rochester, New York, United States

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Manager, Data Analytics

Ortho Clinical Diagnostics

Rochester, New York, United States

Rochester, New York, United States

À propos

Manager, Data Analytics – QuidelOrtho The Manager, Data Analytics is a global people leader within QuidelOrtho's Global Quality & Compliance (GQ&C) organization. This role 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 support business agility, innovation, and growth. Responsibilities Provide independent guidance to business partners on quality data handling and analytics. Establish dashboards and data visualizations to support product quality and continuous improvement. Lead metrics and data analytics work for Complaints, Recalls, non-conformances (NC), CAPA, audits/compliance, and other areas of Quality. Manage complaint‑trending activities and related software system validations. Compile and present quality data and analysis to the business, e.g., Management Review. 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 21CFR820, IVDR, and other applicable requirements. Drive harmonization and standardization of Quality processes, procedures, and tools across sites and functions to strengthen compliance and efficiency. 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 team members 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. Identify and drive process improvements; own process investigations, nonconformance records, or corrective actions in response to audit findings. Perform other work‑related duties as assigned. Work in a hybrid setting at any global QuidelOrtho site. Qualifications Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline. 7+ years of progressive experience in Quality, Compliance, or related fields within the Medical Device, IVD, or Biopharmaceutical industries, including at least 3 years in people leadership. Strong understanding of Quality System regulations and standards, including ISO13485, FDA21CFR820, and IVDR. 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 Skills and Experience 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. Experience supporting or leading Health Authority or Notified Body inspections. Key Interactions Internal: Operations, Supply Chain, R&D, Commercial, Regulatory Affairs, GSO, Quality & Compliance teams globally and regionally. External: Regulatory agencies, Notified Bodies, contract manufacturers, suppliers, and service providers. Work Environment & Physical Demands Typical office or laboratory environment with virtual collaboration across multiple global sites. No strenuous physical activity required. May include occasional travel for site visits, leadership meetings, or regulatory support. Benefits Salary range: $102,000 to $133,000; bonus eligible. Comprehensive benefits package including medical, dental, vision, life, and disability insurance; 401(k) plan; employee assistance program; Employee Stock Purchase Plan; paid time off (including sick time) and paid holidays. Equal Employment Opportunity QuidelOrtho believes in equal opportunity for all and is committed to ensuring that all individuals, including those with disabilities, have an opportunity to apply for positions 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.
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Rochester, New York, United States

Compétences linguistiques

English

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