Position Brand Description:

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.

Key Objectives/Deliverables:

Compliance Oversight & Governance

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)

Computer System Validation (CSV) / CSA

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)

System Lifecycle Compliance

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

Risk Management & Regulatory Classification

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

Audit & Inspection Readiness

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)

Change Control & Continuous Compliance

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

Supplier & Third-Party Oversight

Ensure vendors comply with validation and quality expectations
Review supplier documentation, validation evidence, and deliverables
Support third-party risk management activities

Cross-Functional Collaboration

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.

Basic 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.

Additional Preferences:

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.

Education Requirements:

BS/BA in Computer Science or related field required (or equivalent work experience).

Other Information:

Travel 10% possible.
Lifting not required.
May be required to be on call.

This role is exempt and the anticipated compensation for this role is $71,250 - $116,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs; relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.