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

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

Senior Manager, TM Testing

Key skills