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Biological Product Design Owner

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Baxter

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Location:
Belgium , Braine-l'Alleud

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Category:
Research and Development

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

This role is responsible for managing technical outcomes through indirect management of individuals and teams, handling Design Control, CAPA, and Change Control projects, providing design leadership, and ensuring compliance with quality standards and regulatory requirements.

Job Responsibility:

  • Achieves desired technical outcomes through the indirect management of individuals and teams(s) and the direct completion of complex Design Control, Corrective Action Preventative Action (CAPA), Change Control (CC) projects or programs within the boundaries of timing and budget
  • Reviews and approves complex design changes with technical staff and provides technical product direction
  • Provides technical and design-leadership
  • Fosters an environment of rigor, completeness, and compliance when participating on plant CAPA, CC or Field Corrective Action investigations/assessments
  • Responsible for technical and project management of a constantly changing initiative portfolio
  • Responsible for triage escalation to global R&D team members and managing stakeholder expectations
  • Manages innovative technical solutions to complex product-related problems
  • Maintains current knowledge of relevant quality standards and regulatory requirements

Requirements:

  • Relevant technical discipline, preferably an advanced degree in Chemistry/Biology/Chemical Engineering or equivalent
  • 1 up to 5 years of experience with a Bachelor degree or 0 up to 2 years of experience with a Master degree
  • Excellent communication skills – both written and oral
  • Ability to work effectively independently and in team environment
  • Familiarity with applicable quality and regulatory standards for medical devices, drugs and biologics
  • General working knowledge of standards related to design control, change control, CMC, material qualification, process qualification, validation, and risk management, for biologic drugs
  • Comfortable in analyzing and solving complex problems within a risk-based approach
  • Aptitude in managing cross-functional, cross-facility teams and projects of a diverse nature

Nice to have:

  • Familiarity with applicable quality and regulatory standards for medical devices, drugs and biologics
  • General working knowledge of standards related to design control, change control, CMC, material qualification, process qualification, validation, and risk management, for biologic drugs
What we offer:
  • Support for Parents
  • Continuing Education/Professional Development
  • Employee Health & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
March 20, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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