EMEA Regional Quality Integration Leader

Job Description

About the Role The EMEA Regional Quality Integration Leader will be responsible for leading and coordinating quality integration activities across the Europe, Middle East, and Africa regions, ensuring adherence to regulatory requirements and internal quality standards following mergers, acquisitions, or significant process changes. This is an outstanding opportunity to develop the quality landscape of our organization in a region that spans multiple countries and regulatory environments.

Main Responsibilities

• Develop and carry out regional quality integration strategies and plans that align with global quality objectives and local regulatory frameworks.
• Guide cross-functional teams through the integration of quality management systems (QMS), processes, and procedures for newly acquired entities or major business changes within the EMEA region.
• Conduct gap analyses of existing quality systems against BD standards and applicable regulations (e.g., ISO 13485, MDR, IVDR), developing and implementing remediation plans.
• Harmonization of quality documentation, training programs, and quality metrics coordinated across integrated sites.
• Act as the primary point of contact for quality integration matters with regional business leaders, global quality teams, and regulatory affairs.
• Ensure effective communication and change management strategies are in place to support successful quality integration.
• Monitor and report on the progress of quality integration initiatives, identifying and mitigating potential risks.
• Participate in due diligence activities for potential acquisitions from a quality perspective.
• Provide expert mentorship and support on quality integration challenges to regional teams.
• Foster a culture of continuous improvement and quality excellence throughout the integration process.

About you

Bachelor's degree or equivalent experience in a scientific, engineering, or related field. Master's degree preferred. Minimum of 8-10 years of experience in Quality Assurance in the medical device or pharmaceutical industry. At least 3-5 years must be in a leadership or management role. Established background in guiding and handling quality system integrations associated with mergers, acquisitions, or substantial organizational shifts. Comprehensive understanding of applicable medical device regulations (e.g., ISO 13485, EU MDR, IVDR, FDA QSR). Solid knowledge of quality management concepts, tools, and approaches (e.g., CAPA, FMEA, lean manufacturing). Proven capability to guide and impact cross-functional teams within a complex, matrixed organization. Excellent communication, interpersonal, and presentation skills with the ability to engage collaborators at all levels. Strong analytical and problem-solving abilities. Fluency in English required; proficiency in other major European languages (e.g., German, French) is a significant advantage. Willingness to travel regularly throughout the EMEA region (up to 40-50%). This role is perfect for someone who thrives in a dynamic environment and is excited by the challenge of integrating quality systems across diverse regions and cultures.

Primary Work Location

BEL Erembodegem - Dorp 86

Additional Locations

POL Warsaw - ul. Cybernetyki

Work Shift

At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role.

Salary Range Information

Salary Range Information €105,800.00 - €161,375.00 EUR Annual

Why Join Us?

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you’ll discover a culture in which you can l