Project Manager, Technical Life Cycle Management, Incoming Material

Role Summary

Project Manager, Technical Life Cycle Management, Incoming Material. Lead technical projects supporting the qualification of primary packaging components for sterile products, drive continuous improvement, and ensure compliance across manufacturing, quality, and regulatory teams in a highly regulated environment.

Responsibilities

• Lead technical projects supporting the qualification of primary packaging components for sterile products, ensuring alignment with standards.
• Develop and implement continuous improvement projects, including preparing business cases and managing budgets.
• Maintain and share process and product knowledge across manufacturing, quality, and regulatory teams.
• Prepare and manage risk assessments for incoming materials, identifying opportunities for improvement.
• Act as a key contact during internal and external audits, providing expertise on processes and materials.
• Ensure compliance with quality and regulatory requirements while driving operational excellence.

Qualifications

• Required: Bachelor’s degree in a scientific or technical field (e.g., chemistry, bioengineering, life sciences).
• Required: Minimum of 5 years of experience in biopharmaceutical manufacturing or related fields (e.g., QA, QC, regulatory affairs).
• Required: Proven experience in project management, including leading cross-functional teams.
• Required: Strong understanding of compliance requirements in a regulated environment.
• Required: Excellent communication skills, both written and verbal, in English.
• Required: Ability to analyze data and manage complex projects effectively.
• Preferred: Expertise in managing incoming materials within a pharmaceutical or biopharmaceutical setting.
• Preferred: Proficiency in French or other languages.
• Preferred: Experience with continuous improvement methodologies (e.g., Lean, Six Sigma).
• Preferred: Strong problem-solving and decision-making skills.
• Preferred: Ability to influence and collaborate across diverse teams and stakeholders.
• Preferred: Familiarity with project management tools and processes.

Skills

• Project management
• Regulatory compliance
• Process knowledge management
• Risk assessment
• Auditing and supplier/material qualification
• Data analysis and decision making

Education

• Bachelor’s degree in a scientific or technical field (e.g., chemistry, bioengineering, life sciences)

Additional Requirements

• On-site role based in Belgium; strong collaboration with cross-functional teams.