QA Project Engineer - Vendor management (global)

QA Project Engineer - Vendor management (global)

Location: Ghent (remote position)

Position Summary: We are seeking a proactive and detail-oriented QA Project Engineer - Vendor management (global) to join our team. This role will be instrumental in ensuring harmonized and consistent change control processes across our pharmaceutical external manufacturing network. The successful candidate will support the development, effective implementation, and continued maintenance of Change Controls to ensure compliance and meet industry standards.

Essential Job Duties and Responsibilities:

Change Control Execution:

• Execute External Supply change control processes in conformance with current standards and procedures, using applicable system application tools.
• Ensure the integrity, consistency, and compliance of processes for all innovative medicine.
• Assure successful implementation of changes and actions by following up and synchronizing activities for all participants.
• Communicate status updates for implementations to key stakeholders.
• Provide product and Supply Chain knowledge to ensure proper implementation and compliance.

Relationship Management:

• Actively develop and manage relationships with process users, business owners, affiliates, and external organizations.
• Partner with other areas of the Supply Chain to foster effective collaborations.
• Maintain compliance with all company policies and procedures.
• Ensure audit readiness of the global change control process.

Additional Responsibilities:

• Perform related duties as assigned by the supervisor.
• Maintain a high level of compliance and readiness for audits.

Minimum Qualifications:

• Bachelor's degree in Physical or Life Science, Supply Chain, or Chemical Engineering.
• 1-3 years of related experience, with significant experience in the pharmaceutical or other highly regulated industries.
• Knowledge of Quality Systems processes, including cGMP and FDA regulations.
• Ability to comprehend, analyze, and interpret process and systems information, technical procedures, reports, and regulations to make decisions in a GMP environment.
• Proven ability to perform independent work requiring attention to detail, accuracy, and scientific judgment.
• Excellent interpersonal, written, and oral communication skills, with the ability to utilize active listening skills to understand concerns and build relationships.
• Strong interpersonal skills, business partnering, influencing, and negotiating skills to develop and maintain effective business partnerships.
• Proficiency in managing supplier relationships.
• Proficient in Microsoft (MS) Word, Excel, and PowerPoint.
• Experience with Process Compliance/TrackWise is heavily preferred.
• Experience in the medical device or pharmaceutical industry is desirable.
• Strong project management skills.
• Demonstrated experience leading complex change implementations confidently.

Why Join Us:

• Be part of a dynamic team that is integral to the success of our pharmaceutical supply chain management.
• Engage in meaningful work that ensures the delivery of critical pharmaceutical products.
• Collaborate with cross-functional teams and external partners.
• Competitive compensation and benefits package.

Application Process: If you meet the qualifications and are excited about the opportunity to contribute to our team, please submit your resume and cover letter to gillescarpentier(at)realstaffing.com