Biological Product Design Owner, Baxter

Baxter

Location:
Belgium, Braine-l'Alleud

Category:
Research and Development

Contract Type:
Employment contract

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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Biological Product Design Owner