EMEA Regional Quality Integration Leader

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

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

We are the people who give possibilities purpose

BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Description

About the Role

Main Responsibilities will include

• 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. Join us and be a part of a team that is committed to clinical excellence and patient safety!

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 learn, grow and thrive.

We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.

To learn more about BD visit https://bd.com/careers.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

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".

Salary Range Information

€105,800.00 - €161,375.00 EUR Annual