EMEA Regional Quality Integration Leader

BD; Województwo mazowieckie; Sur place; PLN 464 000 - 708 000; Plein temps

Résumé du poste

BD is seeking a seasoned Quality Integration Leader to drive regional quality integration strategies across the EMEA region. You will guide cross-functional teams through QMS integrations for newly acquired entities and major business changes, aligning with ISO 13485, MDR, IVDR and FDA QSR.

The ideal candidate has 8–10 years in QA in medical devices/pharma, with 3–5 years in leadership, and strong change management abilities. Willingness to travel up to 40–50% is required.

Qualifications

• Minimum 8–10 years in Quality Assurance in the medical device or pharmaceutical industry.
• At least 3–5 years in a leadership or management role.
• Experience guiding quality system integrations for mergers, acquisitions, or major organizational shifts.
• Strong knowledge of ISO 13485, EU MDR, IVDR, FDA QSR.

Responsabilités

• Develop regional quality integration strategies aligned with global objectives.
• Guide cross-functional teams through QMS integrations for newly acquired entities or major changes.
• Conduct gap analyses against BD standards and applicable regulations (ISO 13485, MDR, IVDR, FDA QSR).
• Harmonize quality documentation, training, and metrics across integrated sites.
• Act as primary contact for quality integration with regional leaders, global quality teams, and regulatory affairs.
• Ensure effective communication and change management for quality integration.
• Monitor and report progress, identifying risks and remediation actions.
• Participate in due diligence activities from a quality perspective.
• Provide mentorship on quality integration challenges to regional teams.
• Foster culture of continuous improvement and quality excellence.

Connaissances

Quality leadership

Regulatory knowledge

Cross-functional leadership

Quality system integrations

CAPA

FMEA

Lean manufacturing

Communication

Problem-solving

Travel readiness

Formation

Bachelor's degree

Master's degree preferred

Outils

ISO 13485

Description du poste

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

• 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.

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

€105,800.00 - €161,375.00 EUR Annual