EMEA Regional Quality Integration Leader

About the role

Following the combination of BD Biosciences and Diagnostic Solutions with Waters Corporation, BD is looking for an EMEA Regional Quality Integration Leader. The role leads and coordinates quality integration activities across Europe, the Middle East and Africa, ensuring adherence to regulatory requirements and internal quality standards after mergers, acquisitions or major process changes. The position is based in Erembodegem, Belgium.

Key responsibilities

• Develop and run regional quality integration strategies and plans aligned with global quality objectives and local regulatory frameworks.
• Guide cross-functional teams through the integration of quality management systems, processes and procedures for newly acquired entities or major business changes in EMEA.
• Conduct gap analyses of existing quality systems against BD standards and regulations (e.g. ISO 13485, MDR, IVDR) and implement remediation plans.
• Harmonize quality documentation, training programs and quality metrics across integrated sites.
• Act as the main contact for quality integration with regional business leaders, global quality teams and regulatory affairs.
• Ensure effective communication and change management, monitor progress of integration initiatives and mitigate risks.
• Participate in due diligence for potential acquisitions from a quality perspective and mentor regional teams.

Required profile

• Bachelor's degree or equivalent experience in a scientific, engineering or related field; master's degree preferred.
• 8-10 years of experience in Quality Assurance in the medical device or pharmaceutical industry, with 3-5 years in a leadership or management role.
• Background in guiding quality system integrations linked to mergers, acquisitions or major organizational shifts.
• Fluency in English; proficiency in other major European languages is a significant advantage.
• Willingness to travel regularly across EMEA (up to 40-50%).

Required skills

• Knowledge of medical device regulations (ISO 13485, EU MDR, IVDR, FDA QSR).
• Quality management concepts and tools such as CAPA, FMEA and lean manufacturing.
• Ability to lead cross-functional teams in a complex, matrixed organization.