IT Compliance Analyst
About The Position
This position is responsible for delivering, maintaining, and supporting products and solutions in a way that drives business value while ensuring alignment with GxP requirements, data integrity principles and regulatory expectations. The IT Compliance analyst helps enable business effectiveness by identifying opportunities across business areas for leveraging technology, process, and information while maintaining or improving compliance. The IT compliance analyst identifies systems requirements and recommends appropriate compliance strategies for delivering changes to systems, new systems, or retirement of systems. They serve as thought leader, influence evolution of internal standards, adoption of compliance strategies and frameworks, enhancement of existing processes, and drive process changes. This role will collaborate with Branchburg and HQ IT teams to meet goals for both current and anticipated future needs for new and existing technologies, practices and initiatives.
Requirements
- 5+ years of IT or equivalent relevant experience.
- Minimum of 2+ years in the Life Sciences industry.
- Must maintain excellent working knowledge of pharmaceutical regulations (e.g. cGMP’s, 21 CFR Part 11, Computers Systems FDA) and other applicable regulations (e.g. Privacy, OSHA, etc.) related to laboratory and/or manufacturing environment and system applications.
- Ability to work on multiple concurrent project initiatives.
- Experience with managing external (vendor, consultant) business partners.
- Basic understanding of General IT concepts, databases (Oracle, SQL, etc.), operating systems (Windows, etc.), system applications, and network switches.
Nice To Haves
- MS/MBA desirable.
- Previous experience in a regulated environment preferred.
- Effective problem-solving and analytical skills to resolve operational problems.
- Excellent written and verbal communication skills with the ability to develop and present both business and technical presentations.
- Ability to build relationships across dimensions of difference, ask questions and invite others to contribute.
- Demonstrated business acumen.
- Speak up with ideas, concerns and to ensure safety of others.
- Demonstrated learning agility, and ability to think creatively, try new ideas and apply learnings.
- Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
- Strong collaboration with colleagues at all levels.
- Demonstrate courage and integrity.
- Demonstrated success in influencing without authority.
- Strong customer service and teamwork oriented.
- Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
- Highly flexible, adapting to changes in priorities, requirements and processes is required.
Responsibilities
- Provide independent quality oversight for computerized systems across their lifecycle
- Ensure compliance with internal SOPs and regulatory expectations
- Serve as quality authority for validation and lifecycle controls
- Interpret and communicate regulatory expectations (FDA, EMA, GAMP 5)
- Oversee validation strategy and ensure systems meet risk-based validation principles
- Review/approve validation deliverables (plans, test scripts, traceability, reports)
- Verify validation evidence is complete, accurate, and inspection-ready
- Support transition from CSV → CSA (critical thinking, unscripted testing, risk focus)
- Ensure adherence to lifecycle controls: Change Control, Incident / Problem Management, CAPA management, Periodic Reviews, System Retirement
- Confirm systems remain in a validated state throughout lifecycle
- Lead or approve system risk assessments and regulatory classification
- Apply risk-based decision making to validation and controls
- Ensure alignment with data integrity and electronic records requirements
- Represent IT compliance/validation during internal and external audits
- Provide documentation and defend validation approach to auditors
- Identify compliance gaps and drive remediation actions (CAPAs)
- Ensure all system changes meet validation and documentation requirements
- Provide oversight of testing, documentation updates, and closure criteria
- Prevent unauthorized or uncontrolled system changes impacting GxP processes
- Ensure vendors comply with validation and quality expectations
- Review supplier documentation, validation evidence, and deliverables
- Support third-party risk management activities
- Partner with Technical System Owners (TSO), Business Process Owners (BPO), Quality (BQA / CSQA)
- Provide guidance on compliant design, testing, and operations
- Collaborate with QA on Defect Management, Deviation Management and Root Cause Analysis activities.
- Perform Deviation Lead Investigator function for the IT organization.
Benefits
- paid time off (holidays, vacation, and additional leave)
- medical, dental, and vision insurance
- life insurance
- a company-matched retirement savings plan
- wellness programs
- short- and long-term disability benefits
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
