Operational Excellence & IT Compliance Lead

Job Description

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:

Site Operational Excellence Leadership

Lead the site Operational Excellence strategy, governance model, and continuous improvement roadmap in alignment with business priorities, quality expectations, and site performance objectives.
Establish and sustain a culture of continuous improvement by engaging leaders and employees in problem solving, standard work, visual management, and performance management practices.
Partner with site leadership to identify, prioritize, and execute improvement opportunities that increase compliance, efficiency, reliability, and business value.
Define and monitor site-level Operational Excellence metrics, improvement initiatives, and benefits realization to ensure measurable and sustainable outcomes.

IT Compliance Oversight & Governance

Provide leadership oversight for IT Compliance activities supporting GxP computerized systems across the system lifecycle.
Ensure compliance with internal SOPs, data integrity principles, 21 CFR Part 11 expectations, and applicable regulatory standards including FDA, EMA, and GAMP 5 guidance.
Serve as a site-level quality and compliance partner for validation strategy, lifecycle controls, inspection readiness, and risk-based decision making.
Influence the evolution of site and global standards, compliance frameworks, and operating practices to support current and future business needs.

Operational Excellence Program Execution

Lead cross-functional improvement initiatives using structured problem-solving, Lean, Six Sigma, root cause analysis, and change management practices as appropriate.
Coach teams in identifying process waste, variation, compliance risk, and performance gaps, and guide teams toward practical, sustainable solutions.
Facilitate governance forums, workshops, and performance reviews to align stakeholders, remove barriers, and maintain momentum on priority initiatives.
Promote standardization of processes, tools, and operating rhythms across the site to support reliable execution and scalability.

System Lifecycle Compliance

Ensure IT systems remain in a validated and compliant state throughout the lifecycle, including implementation, operation, change, periodic review, and retirement.
Provide oversight for change control, incident/problem management, CAPA management, periodic reviews, access reviews, and system retirement activities.
Confirm system changes meet validation, testing, documentation, approval, and closure requirements before release or implementation.
Prevent unauthorized or uncontrolled changes that may impact GxP processes, data integrity, or business continuity.

Risk Management, Audit Readiness & Remediation

Lead or approve system risk assessments, regulatory classifications, and control strategies for GxP computerized systems.
Represent IT Compliance and validation topics during internal audits, external audits, regulatory inspections, and quality reviews.
Identify compliance gaps, operational risks, and recurring issues, and drive remediation actions through CAPA, deviation management, and continuous improvement processes.
Ensure alignment with data integrity, electronic records/electronic signatures, security, and business continuity expectations.

Cross-Functional Leadership & Business Partnership

Partner with site leadership, Technical System Owners, Business Process Owners, Quality, Operations, Engineering, Digital/IT, and global/HQ teams to drive aligned execution.
Provide guidance on compliant system design, testing, operations, deviation management, defect management, root cause analysis, and sustainable process improvement.
Serve as a leadership point of contact for Operational Excellence and IT Compliance priorities, escalations, risks, and decision-making forums.
Perform or oversee the Deviation Lead Investigator function for the IT organization, ensuring timely, thorough, and well-documented investigations.
Develop communication, training, and change management approaches that help leaders and employees adopt new processes, behaviors, and compliance expectations.

Basic Requirements:

8+ 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 Lean tools and principals including Six Sigma methodologies
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 $145,500 - $242,500.

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.

Learn more about this Employer on their Career Site