Manager, Microbiology

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.

As we continue to grow as one QuidelOrtho we are seeking a Manger Microbiology. The Manager Microbiology 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 Quality Controlensuring alignment with global regulatory requirements (ISO 13485 FDA 21 CFR 820 IVDR and other applicable standards). The Quality & Compliance Manager partners cross-functionally to embed Quality and Compliance principles throughout the product lifecycle driving harmonization inspection readiness and continuous improvement. The Microbiological Testing Manager is responsible for the strategic oversight technical leadership and operational management of microbiological testing activities supporting the development manufacture release and lifecycle management of in vitro diagnostic (IVD) products across a global organization. This role ensures that microbiological testing is scientifically sound compliant with global regulatory requirements and aligned with business and product quality objectives. 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 ensures that Quality systems and teams deliver sustainable business and compliance outcomes.

This position will be onsite in Pompano Beach Florida or Rochester NY.

• 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.

• 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.

• Provide subject matter expertise in microbiological testing relevant to IVD products including but not limited to sterility bioburden endotoxin microbial identification and environmental monitoring.

• Implement and maintain microbiological testing strategies to support product development validation manufacturing and ongoing compliance.

• Ensure appropriate risk-based approaches are applied to microbiological controls throughout the product lifecycle.

• Lead and manage microbiology laboratories and/or external testing partners across multiple global sites.

• Ensure timely and accurate execution of testing to support manufacturing batch release and project timelines.

• Ensure team provide microbiological input to design reviews risk assessments supplier qualifications and process validation activities.

• Ensure oversight within the team of laboratory investigations deviations OOS/OOT results CAPAs and change controls related to microbiological testing.

• Perform other work-related duties as assigned.

Required:

• Bachelors degree in Life Sciences Engineering or a related technical discipline required.

• 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 ISO 13485 FDA 21 CFR 820 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:

• 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.

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

External: Regulatory agencies Notified Bodies Contract manufacturers Suppliers and service providers.

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

No strenuous physical activity required. May include occasional travel for site visits leadership meetings or regulatory support.

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 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 $102000 to $133000 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.

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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