Lead and manage Computer System Assurance (CSA) and IT qualification efforts for systems and applications in core GxP functions – primarily Research, Commercial and Cell Therapy functions.
Supervise junior to mid-level team members assigned to IT and Compliance programs to ensure effectiveness, efficiency, consistency, quality of work and compliance with external regulations and internal procedures.
Collaborate with cross functional and multi-location IT Delivery teams, business users and internal Global Quality compliance staff to ensure that CSA activities are planned and executed in accordance with internal procedures.
Evaluate, propose, and implement AI based technology solutions that improve digitization, compliance, and productivity.
Serve as a CSA subject-matter-expert in support of internal and external regulatory inspections.
Participate in internal and external audits and inspections, providing validation-related support and documentation.

Requirements

A minimum of 12-15 years of experience in IT Compliance and computer systems validation (CSV) in the pharmaceutical industry, including at least 5 years of managing/overseeing IT Compliance and CSV projects.
Good understanding (mandatory) of Computer Software Assurance (CSA), 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP methodologies and Agile methodologies.
A minimum of 3-5 years of experience in planning and implementing validation strategies across GxP ecosystems and preferable experience in Pharmaceutical Research and Manufacturing domains.
2-3 years of experience in using tools like ServiceNow, ALM and Veeva platforms (highly preferable).
General knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software tools.
Good knowledge (mandatory) of IT testing practices and methodologies in the Pharma GxP space and good working knowledge of tools like ALM etc.
Ability to make decisions that impact own work and other groups/teams and works under minimal supervision.
Demonstrates openness to learning and developing. Takes responsibility for their own and team’s development and growth.
Written communication skills, including the ability to deliver clear and articulate presentations.

Benefits

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval), 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees).

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

IT Compliancecomputer systems validationComputer Software Assurance21 CFR Part 11EU Annex 11Data Integrity principlesGAMP methodologiesAgile methodologiesvalidation strategiesIT testing practices

Soft Skills

decision makingopenness to learningresponsibilityteam developmentwritten communicationpresentation skills