EMEA Quality Integration Leader — Regulatory & M&A Focus

BD; Erembodegem; On-site; EUR 106,000 - 161,000; Full time

Job summary

BD is seeking a senior Quality Integration leader to drive regional quality integration strategies across the EMEA region. You will guide cross-functional teams through QMS integrations for acquisitions, perform gap analyses, and harmonize documentation and training to ensure BD standards and regulatory compliance.

The role requires 8–10 years in QA in medical devices/pharma, 3–5 years in leadership, and a strong ability to engage stakeholders across a matrixed organization.

Qualifications

• 8–10 years of QA experience in the medical device or pharmaceutical industry.
• 3–5 years in a leadership or management role.
• Experience guiding quality system integrations in mergers or acquisitions.
• Strong knowledge of ISO 13485, EU MDR, IVDR, and FDA QSR.
• Excellent communication and stakeholder management skills.
• Willingness to travel 40–50% across the EMEA region.

Responsibilities

• Develop regional quality integration strategies aligned with global objectives.
• Lead QMS integration for acquired entities across the EMEA region.
• Conduct gap analyses against BD standards and implement remediation plans.
• Harmonize quality documentation, training, and quality metrics across sites.
• Mentor regional teams on quality integration challenges.
• Support due diligence from a quality perspective.

Skills

Leadership

Quality assurance

Regulatory compliance

Cross-functional collaboration

Communication

Travel willingness

Problem solving

English fluency

German/French (advantage)

Education

Bachelor's degree or equivalent

Master's degree preferred

Tools

CAPA

FMEA

Lean manufacturing

Job description

BD is seeking a senior Quality Integration leader to drive regional quality integration strategies across the EMEA region. You will guide cross-functional teams through QMS integrations for acquisitions, perform gap analyses, and harmonize documentation and training to ensure BD standards and regulatory compliance.

The role requires 8–10 years in QA in medical devices/pharma, 3–5 years in leadership, and a strong ability to engage stakeholders across a matrixed organization.