Manager, Digital Quality and Governance

Bristol Myers Squibb

5 - 10 years

15 - 20 Lacs

hyderabad

Posted:2 days ago| Platform:

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Skills Required

computer science erp manager quality assurance sap clinical trials agile life sciences oracle continuous improvement risk management

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

B.E./B.Tech. or equivalent in computer science, engineering, life science field
A minimum of 5+ years of experience in Quality Assurance, IT Compliance and computer systems validation (CSV) in the pharmaceutical industry
Candidate must have a strong understanding of 21 CFR Part 11, EU Annex 11 , Data Integrity principles, GAMP and Agile methodologies. Additionally, good understanding of Computer Software Assurance principles desired.
Understanding of quality risk-management concepts (ICH Q9) preferred
Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures
Previous experience as a computer system validation / quality assurance / quality control analyst for a life sciences company regulated by the FDA (or equivalent) preferred
Familiarity with the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes
Experience with driving validation strategies across across the end-to-end product lifecycle as well as experience with widely used IT Enterprise platforms (MES, SAP, Veeva, Service NOW etc.)
General knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software tools
Candidate must have strong knowledge of IT testing practices and methodologies in the pharmaceutical GxP space-and good working knowledge of tools like ALM and Valgensis
Ability to make decisions that impact own work and other groups/teams and works with minimal supervision
Ability to support various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team
Demonstrates openness to learning and developing. Takes a responsibility for their own and team s development and growth
Demonstrates an understanding of factors driving team performance and how they contribute to the teams overall success
Strong sense of ethics, diplomacy and discretion
Commitment to Quality
Fluent in English, with proven professional working proficiency in English for reading, writing and speaking. including the ability to deliver clear and articulate presentations

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