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QA Operations Manager

QA Operations Manager

DanaherLogan, UT, US
Hace más de 30 días
Tipo de contrato
  • A tiempo completo
Descripción del trabajo

QA Operations Manager

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher's 15+ operating companies, our work saves livesand we're all united by a shared commitment to innovate for tangible impact.

You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

The QA Operations Manager is responsible for leading and managing quality assurance activities that support manufacturing operations across all production value streams. This role ensures the integrity of products manufactured, received, and shipped, while maintaining compliance with regulatory requirements, industry standards, and internal Quality Management System (QMS) procedures.

This position reports to the Senior Manager, Quality Assurance and is part of the Quality Assurance department located in Logan, Utah and will be an on-site role.

What you will do :

  • Lead and oversee QA support for manufacturing operations, ensuring alignment with production schedules and quality standards. Manage the timely review and disposition of batch records and product release documentation.
  • Direct the investigation and resolution of deviations, non-conformances, and quality issues, ensuring root cause analysis and implementation of effective corrective actions. Ensure compliance with QMS requirements, including documentation control, change management, and audit readiness. Monitor and report on key quality metrics, identifying trends and driving continuous improvement efforts.
  • Collaborate with cross-functional teams including Manufacturing, Engineering, Supply Chain, and Regulatory Affairs to support operational goals and quality initiatives. Support internal and external audits, regulatory inspections, and certification processes (e.g., ISO). Develop and mentor QA staff, fostering a culture of accountability, collaboration, and quality excellence. Drive standardization and optimization of QA processes across value streams to improve efficiency and consistency.

Who you are :

  • Bachelor's degree from an accredited institution with 5+ years of experience or 7-10 years of experience may be considered in lieu of a degree.
  • Strong working knowledge of GMP, QMS principles, and regulatory requirements (FDA, ISO, etc.).
  • Proven experience and ability to lead teams, manage cross-functional projects, and influence at all levels of the organization.
  • Ability to collect metric data, analyze and create a representation, present findings to key stakeholders, and identify trends.
  • Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job.

    Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

    Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

    We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and / or to receive other benefits and privileges of employment, please contact : 1-202-419-7762 or applyassistance@danaher.com.

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