- Functional and Technical QA review and approval of validation deliverables associated with various BMS enterprise systems, including but not limited to clinical study databases, electronic Case Report Forms (eCRFs), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, ERP systems including SAP and Oracle, Veeva-based systems such as Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF), Regulatory Information Management (RIM), and Quality Management Systems (QMS), as well as various Veeva Vault-based configurations.

- Ensure adequate and timely quality assurance / regulatory compliance support.

- Provide support during regulatory agency and third party inspections.

- Research new technologies, understand existing processes, and reference recognized standards and frameworks.

- Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.

- Identify opportunities for continuous improvement.

- Adherence to BMS Core Behaviors.

- Conduct risk & impact assessment to determine the extent of validation and qualification and ensure right sized validation effort for programs.

- Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems.

- Implement organizational IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements.

- Review Periodic Review assignments completions for applications in a timely manner.

- Support responses to application CAPAs and Audits as they relate to health authority investigations and internal audits in a timely manner-in coordination with multiple stakeholder teams.

Qualifications & Experience:

- An accredited degree in Computer Science, Engineering, or a Life Sciences-related field.

- Minimum 3 years of experience in Quality Assurance, IT Compliance, or Computer Systems Validation (CSV) within the pharmaceutical, healthcare, or other regulated industries.

- Relevant internships, academic projects, or certifications are a plus.

- Basic understanding of industry regulations such as 21 CFR Part 11, EU Annex 11, and Data Integrity principles.

- Interest in developing deeper knowledge of GAMP, Agile methodologies, and Computer Software Assurance (CSA).

- Awareness of GxP compliance and its importance in managing electronic records and signatures.

- Introductory exposure to enterprise platforms such as ERP systems (SAP, Oracle), Manufacturing systems (MES, ELN), Veeva Vault-based applications (CTMS, eTMF, RIM), Quality Management Systems (QMS).

- Foundational knowledge of IT infrastructure, including SaaS, databases, and basic system architecture is advantageous.

- Awareness of IT testing principles in regulated environments.

- Eagerness to gain hands-on experience with tools such as HP ALM and ValGenesis.

- Fast learner with strong curiosity and commitment to building domain expertise.

- Demonstrates initiative, ownership, and accountability for tasks.

- Collaborative mindset with the ability to work effectively in cross-functional teams.

- Strong communication and organizational skills, with an analytical approach to solving problems.

- Professional proficiency in English (reading, writing, and speaking), with the ability to contribute to clear documentation and presentations.

- If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.

- You could be one step away from work that will transform your life and career.

- Uniquely Interesting Work, Life-changing Careers.

- With a single vision as inspiring as Transforming patients' lives through science- , every BMS employee plays an integral role in work that goes far beyond ordinary.

- Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.