Senior Validation and Compliance Architect

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The role of Senior Validation and Compliance Architect will be accountable, like everyone in the Computer System Validation (CSV) Center of Excellence (CoE), for performing processes relative to the SDLC and validation services for BD applications and provide GxP guidance to project groups.

This position works with the Associate Director, IT Validation and Compliance, Global Process Owner (GPO) for CSV to collaborate across IT and with key partners from Corporate Quality, Legal, Internal Audit and Security and associated regional teams. The aim is to ensure appropriate processes defined for BD system development are followed in an efficient and effective manner to satisfy business and regulatory requirements.

We are the makers of possible. 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.

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.

Senior Validation and Compliance Architect responsibilities will include:

• Coordinate the periodic review process for systems as their review deadlines come up.
• Work with the GPO CSV to conduct periodic reviews of systems.
• Lead the remediation project for large scale solutions identified through periodic review process.
• Manage communications and training with system business owners for the effective periodic review of their systems.
• Lead special projects where strategic alignment with EU project leadership is critical to success.
• Provide GxP SME support for EU time zone assessments during the BD System Regulatory Assessments (SRA).
• Act as lieutenant GPO CSV in the EU (regional point of contact for validation questions and concerns for EMEA).

Ideal candidate experience and qualifications:

• 8+ years’ experience in SDLC/CSV or related positions in Quality / Compliance activities (preferably Pharmaceutical and / or Medical Device industries).
• Experience in software development and testing.
• Experience in digital workflow management tools and content management solutions.
• Working understanding of software development best practices.
• Expert level understanding of software quality management and validation.
• Bachelor’s degree in IT, data science, informatics or a related field is required.
• Proficient level of English.

Click on apply if this sounds like you!

Salary Range: zł223,900.00 - zł341,425.00 PLN Annual

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.