Site Quality Head |

hace 4 semanas

León, España Importante Empresa Del Sector A tiempo completo

**Job Description Summary**: We are the makers of possibleBD 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.Why join us?A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture.

You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time.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 health. At BD, you'll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place.Become a maker of possible with usOur vision for Biosciences at BDBD Biosciences (BDB) is a leading provider of high-quality flow cytometry and single-cell genomics solutions, scientific research and clinical laboratories. Here, we are leading the way by developing the best technologies that have the ability to look closer at the details of cells and diseases.**About the role**:**As Site Quality Head / Head of Quality you will be** responsible for the Plant Quality Assurance and provide direct management to technical and managerial staff in Salamanca, Spain. The role contributes to the definition of the BDB strategy and resolves tactics required to achieve objectives.

Through outstanding communication; effective problem solving and active management of ambiguous situations; the Quality Head ensures product safety, product quality and compliance with all relevant global regulations and customer expectations.**Main responsibilities will include**:- Perform the function of BD Cytognos SL Management Representative: ensuring that the Quality System Requirements are effectively established and maintained; reporting on the performance to Management with Executive Responsibility for review and the development and implementation of the Quality Plan in conjunction with other Leadership Team members at the plant and home office.- Manages the Quality Assurance and Quality Compliance staff and has oversight over Quality Control activities, New Product Development, and the activities to support the design,

manufacture, and release of clinical and research products that meet established specifications. These activities include: inspection, testing for disposition, quality support, environmental monitoring, validation, material disposition, in-process product disposition, finished goods disposition and release, data collection/trend analysis, quality auditing, Quality/Compliance Training, CAPA, complaint processing & investigation, quality record retention, quality documentation and change control process.- Ensure the functional quality organization is designed and resourced to fulfill its obligations and to align with applicable regulations and procedures.- Mentor and develop personnel,

including dedicated succession planning and contingency management.- Builds and communicates trend analysis of quality indices within the plant and the home office. Through the review process identifies potential CAPA's and confirms efficiency checks- Participates / host investigations from Regulatory Agencies, Notified Bodies, and Customers. Takes the lead in developing, monitoring, and reporting any necessary corrective action strategy.- Participates in BDB or corporate programs or product and process improvement teams.- Promotes awareness of regulatory and customer requirements. Keep tabs on US and International regulations that effect our products. Actively communicates changes to management and staff and provides mentorship on any needed modifications.

Ensures modifications are carried out for continued compliance.- Participates in creating the department budget and pro-actively manages it to targets.- Perform other duties as required.**About you**:- A minimum of 7 years' experience in Quality, Regulatory, or Operations of a Medical Device, IVD, Pharmaceutical or Biotech firm.- A minimum of 3 years directly leading Quality professionals.- Professional certification is preferred (i.E., RAC, CQA, CAE, SQE, CQM, Six Sigma, etc.)- Excellent verbal and written communication skills. (Spanish and English)- Consistent track record to effectively collaborate and partner with all levels of management while maintaining an appropriate and formative style is critical.- Strong problem solving and critical thinking skills including timely issue identification and

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