Onsite Senior Manager, TM Testing

Posted 4 days ago

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About the role

  • Senior Manager overseeing Quality Control testing operations across global locations for QuidelOrtho. Focused on compliance, leadership, and strategic quality improvement initiatives.

Responsibilities

  • Lead and oversee quality control (QC) release testing operations across multiple global locations supporting the Transfusion Medicine line of business
  • Ensure that all release testing activities are executed in compliance with global regulatory requirements, quality system standards, and internal procedures, enabling the timely and compliant release of IVD products to market while also supporting business growth and product lifecycle activities
  • Accountable for developing talent, strengthening scientific and compliance capabilities
  • Perform other work-related duties as assigned

Requirements

  • Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline required
  • 10+ 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

Benefits

  • 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

Job title

Senior Manager, TM Testing

Job type

Experience level

Senior

Salary

$135,000 - $175,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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