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Head of Quality, Contract Development & Manufacturing Organization (CDMO)
Head of Quality, Contract Development & Manufacturing Organization (CDMO)Confidential • Somerset, NJ, US
Head of Quality, Contract Development & Manufacturing Organization (CDMO)

Head of Quality, Contract Development & Manufacturing Organization (CDMO)

Confidential • Somerset, NJ, US
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Head of Quality, Contract Development & Manufacturing Organization (CDMO)

About the Company

Leading manufacturer of high-quality medical thermometers

Industry

Medical Devices

Type

Public Company

Founded

1921

Employees

1001-5000

Categories

  • Health Care
  • Medical
  • Training
  • BioTech
  • Healthcare
  • Medical Equipment
  • Medical Equipment and Supplies

Specialties

  • terumo interventional systems markets medical devices for endovascular procedures : peripheral embolization
  • transradial access
  • introducer sheaths
  • guiding sheaths
  • guidewires
  • angiographic catheters
  • coronary catheters
  • microcatheters
  • embolics
  • transradial solutions
  • terumo medical corporation's businesses market medical devices including : peripheral embolization
  • and embolics

    • Business Classifications

  • B2B
  • Enterprise

    • About the Role

    The Company is seeking a Head of Quality for its new Contract Development and Manufacturing Plant in Nordrhein-Westfalen. The successful candidate will be responsible for leading the development and execution of the quality strategy within a dynamic CDMO environment, ensuring the delivery of safe, compliant, and high-quality products to global customers. This pivotal role involves strategic leadership, quality governance, regulatory compliance, stakeholder engagement, organizational development, performance management, and continuous improvement. The Head of Quality will be a key leader, collaborating across departments, and representing the company in high-stakes customer and regulatory settings. Applicants for the Head of Quality position should have a University degree, with a Master's degree preferred, and at least 10 years of experience in quality within a CDMO sterile manufacturing environment. A minimum of 5 years of managerial experience is required, with a proven track record in interpreting strategy and delivering results. The role demands in-depth knowledge of quality and regulatory requirements in pharmaceutical / biotech CDMO operations, with a strong emphasis on QA. The ideal candidate will be a strategic thinker, possess excellent communication and stakeholder management skills, and have a strong focus on accountability, continuous improvement, and collaborative leadership. Proficiency in German and English is essential for professional conversations.

    Hiring Manager Title

    Vice-President Quality and Regulatory

    Travel Percent

    Less than 10%

    Functions

  • Operations
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