QA Development Manager

Department Info

The Quality, Regulatory & Vigilance (QR) division is organized into five key groups: Quality Systems, QA Development, Quality Operations, Regulatory Affairs, and Complaint & Vigilance.

QA Development is tasked with ensuring that quality and regulatory requirements are correctly translated into new product designs and process improvements. The department supports the engineering, testing, and production teams to achieve high-quality product standards.

Our mission is to guarantee regulatory compliance and product safety through business-oriented services. Our vision is to be a unified, multidisciplinary team driving continuous improvement via standardization, clear communication, and digital solutions.

Job Summary

As the QA Development Manager, you will lead the QA Development, overseeing team objectives, development, and strategy. You will be responsible for defining organizational structure, aligning resources with engineering and QR priorities, and representing Quality in engineering projects to ensure compliance.

In addition to managing QA activities for new product designs and process improvements, you will oversee the supplier control process and ensure effective training, reporting, and corrective action planning in collaboration with other departments.

Job Responsibilities

Quality Assurance Oversight:

• Champion the voice of Quality in engineering projects, ensuring compliance with industry standards to support high-quality engineering, testing, and production processes.
• Establish and implement robust quality control plans for new product developments to guarantee consistent product quality throughout routine operations.

Continuous Improvement & Process Development:

• Drive continuous improvement by reviewing and approving procedures, validation protocols, and reports, raising the bar for quality within the QA Development processes.
• Ensure a smooth transition of QA activities from Development to Operations, maintaining operational consistency and regulatory compliance.

Supplier Control Management:

• Oversee the supplier control process, aligning procedures with the latest standards and regulations, while providing necessary support and training to other departments.
• Monitor supplier performance, report findings in Quality Improvement Meetings, and lead corrective actions for non-conformities, guiding teams through root cause investigations and action plans.

Cross-functional Collaboration:

• Engage cross-functionally to optimize QA processes, ensuring timely and clear communication between QA Development and other teams.
• Partner with stakeholders to ensure the effective integration of quality and regulatory standards across product lifecycles, enhancing organizational quality and compliance.

Organizational Leadership:

• Define and structure the QA Development team to align with Engineering and QR priorities, optimizing resources to meet organizational needs.
• Lead, mentor, and develop team members by setting clear objectives, providing training, and fostering professional growth within the department.

Profile Description

Education:

• Degree in Industrial Pharmacy, Bio-engineering, Industrial Engineering, Biomedical Sciences, or a relevant scientific field.

Experience:

• At least 10 years in the pharmaceutical or medical device industry, with 5+ years in Quality Assurance or Quality Systems.
• Proven ability in team management and departmental strategy.

Skills & Competencies:

• Strong leadership and people management abilities.
• Knowledgeable in GMP, ISO 13485, and regulatory standards.
• Fluent in Dutch and English, with effective communication and stakeholder management skills.

Offer

At Terumo, we offer more than just a job – it’s a chance to make a meaningful impact and be part of a passionate, high-performing team.
 

• Competitive Rewards: We provide a salary and benefits package that recognizes your dedication.
• Inclusive Team Environment: Join a respectful and inclusive team that values diversity and equality.
• Growth Opportunities: We invest in your personal and professional development through various learning opportunities.
• Work-Life Balance: Enjoy flexible hybrid working.
• Connect with Us: Engage with our team and hiring manager throughout the recruitment process.

Contact Person

Jarne Jans - Talent Acquisition Business Partner EMEA