Senior Manager, Combination Products Lifecycle

Keenova Therapeutics plc

Dublin

Hybrid

EUR 56,000 - 94,000

Full time

7 days ago
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Job summary

Keenova Therapeutics plc is seeking a Manager, Combination Products to oversee technical stewardship, lifecycle management, supplier oversight and long-term support of combination-product assets. The role requires coordination across Quality, Regulatory Affairs, Supply Chain, Manufacturing and external partners to ensure product continuity and regulatory compliance.

The position emphasizes lifecycle execution, product continuity planning and risk assessment, with a hybrid Dublin-based work

Qualifications

  • Bachelor-level degree required in a technical field.
  • Minimum 5 years of experience with medical devices or combination products.
  • Knowledge of design controls, risk management, supplier controls, CAPA, change management, and relevant regulatory requirements.
  • Experience working in cross-functional teams and strong communication skills.

Responsibilities

  • Provide technical stewardship and lifecycle management for combination-product assets.
  • Lead changes to product, component, supplier, manufacturing, and lifecycle processes.
  • Maintain technical strategies, risk assessments, and continuity plans for products.
  • Collaborate with Quality, Regulatory Affairs, Supply Chain, Manufacturing and Technical Operations to ensure compliance and continuity.

Skills

Strong written and verbal comms
Cross-functional collaboration
Independent technical issue evaluation
Lifecycle management experience
Regulatory knowledge awareness

Education

Bachelor's degree in engineering, pharmaceutical sciences, life sciences, or related technical discipline

Job description

Keenova Therapeutics plc is seeking a Manager, Combination Products to oversee technical stewardship, lifecycle management, supplier oversight and long-term support of combination-product assets. The role requires coordination across Quality, Regulatory Affairs, Supply Chain, Manufacturing and external partners to ensure product continuity and regulatory compliance.

The position emphasizes lifecycle execution, product continuity planning and risk assessment, with a hybrid Dublin-based work

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