IT Compliance Expert - GxP

At Nestle Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life, Nature's Bounty, Vital Proteins, Orgain, Nuun, BOOST, Carnation Breakfast Essentials, Peptamen, Compleat Organic Blends, and more. We also have extensive pharmaceutical expertise, offering innovative medicines that aim to prevent, manage, and treat gastrointestinal and metabolic-related diseases.

At Nestle Health Science, we bring our best for better lives. Our people are challenged to bring fresh, diverse views and make bold moves to empower healthier lives through nutrition. We know brilliant ideas can come from anyone, anywhere. Here we embrace the entrepreneurial spirit and collaborate with teams that champion focused and forward thinking. We are committed to fostering professional growth and celebrating the achievements of our people along the way. We offer dynamic career paths, robust development, opportunities to learn from talented colleagues around the globe, and benefits that support physical, financial, and emotional wellbeing.

Join us to innovate for impact and reimagine the future of health and nutrition for patients and consumers.

Position Summary:

As an IT Compliance Expert , you play a crucial part in ensuring the compliance of GxP systems and supporting processes. Your primary responsibilities will include:

• Support IT compliance of GxP systems and supporting processes
• Partner with business stakeholders to ensure GxP systems are maintained in a validated state
• Provide compliant business solutions to business stakeholders.

Your will be responsible for the selection, development, validation and maintenance of enterprise GxP systems, including but not limited to Benchling, Clinisys, Wellsky, Kneat, Ellab, Blue Mountain RAM and supporting infrastructure.

As the IT system owner, you will collaborate closely with business colleague to define and document critical business processes and requirements. You will prioritize requests, create business cases for technology solutions, and manage them through the IT governance process, drive the planning, implementation, validation and support of enterprise GxP applications.

If you are passionate about IT compliance and eager to make a significant impact in a dynamic environment, we invite you to apply.

IMPORTANT NOTE: This position will be either a remote or hybrid role based on the selected candidate's geographic location. Preference will be given to applicants who live within a commutable distance of Bridgewater, NJ, Chicago, IL, Palm Beach Gardens, FL or Long Island, NY.

Key Responsibilities:

Strategy, Design and Delivery:

• Partner with business partners to select, plan, design, install, and validate IT GxP Systems in alignment with industry best practices (e.g., CSA) and NHSc SOP's and Policies
• Establish and Drive governance processes which oversee and deliver critical GxP IT projects and operations.
• Collaborate with Nestle IT and business partner leadership to develop the technology strategy, budget, and roadmap for NHSc IT GxP Systems.
• Provide implementation and technical consultation of new GxP systems to support NHSc product portfolio. Serve as Project Manager for technology implementations, including coordination and management of external vendors and ensuring adherence to corporate GxP SOPs.
• Manage relationships with vendors and external service providers, ensuring high quality service delivery and escalation of challenging issues when appropriate.
• Support Clinical Operations, Biometrics and data management systems to ensure IT GxP compliance

GxP System Operations:

• Oversee application lifecycles for enterprise GxP IT systems, collaborating with business partners, to ensure effective change control, testing, validation, and communication. Act as subject matter expert for IT GxP Compliance Program.
• Partner with QA to manage systems validation, periodic reviews, and vendor coordination.
• Lead or support deviation/incident investigations related to corporate GxP information systems and manage the implementation of identified Corrective Actions / Preventive
• Actions (CAPA) resulting from these investigations.
• Support as needed in external/internal audits and inspections.
• Responsible for managing changes to IT GxP systems and supporting processes

General:

• Develop and measure IT support metrics and implement continuous improvement process and procedures.
• Ensure compliance with application services standards, procedures, documentation requirements and policies.
• Drive continuous improvement in system performance and service quality for GxP applications
• Develop detailed project tasks milestones, status reports and other project documentation to ensure timely and on-budget delivery of projects.
• Ensure compliance with SOPs (Standard Operating Procedures) and WIs (Work Instructions) and documentation standards.
• Ensure regulatory compliance is aligned with industry best practices and standards.
• Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.
• Other responsibilities are performed as assigned or needed.

Experience & Education Requirements:

• BS degree in computer science, information technology or equivalent work experience.
• 7+ plus years of experience supporting enterprise GxP IT systems with experience in the following:
• IT biotech project management experience in a multinational environment.
• Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety, pharmacovigilance, manufacturing, engineering automation, regulatory compliance, quality management and compliance, medical information, or clinical trials applications; and,
• IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical operations
• Knowledge of systems software, operations, capacity management, mid-range servers, PCs, SAAS, and web services. Must have hands on experience in qualifying production servers to meet regulatory requirements.
• Knowledge and expertise with Software as a Service (SaaS) systems, automated process equipment, and clinical data management software in the biotechnology or pharmaceutical industry.
• Experience with Benchling, Clinisys, Wellsky, Kneat, Ellab, Blue Mountain RAM,Veeva, QMS and QDocs,
• Experienced in risk assessments, remediation plans, and corrective and preventive action (CAPA), and in reviewing, modifying, and writing standard operating procedures (SOPs). Technical documentation such as VP, IQ, OQ, Test Protocols, Summary reports)
• Solid applied knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, and GAMP 5, CSA, Data Integrity
• Experience with CSA transformation a plus.
• Experience managing change control processes.
• Must possess excellent communication skills with the proven ability to interface and influence at all levels in the organization.
• Must be detail-oriented with strong analytical, organizational, and problem-solving skills.
• Ability to troubleshoot, research, and solve technically challenging problems involving integrated systems.
• Strong customer service orientation and an understanding of business processes related to pharmaceutical and dietary supplement manufacturing.
• Occasional travel required, as needed about 10%

The approximate pay range for this position is $130,000.00 to $160,000.00.Please note that thepay rangeprovided is a good faith estimate for the position at the time of posting. Final compensation may vary based on factors including but not limited to knowledge, skills and abilities as well as geographic location.

Nestle offers performance-based incentives and acompetitive total rewards package, which includes a401k with company match, healthcare coverage and a broad range ofother benefits. Incentives and/or benefit packages may varydepending on the position. Learn more atAbout Us |Nestle Careers (nestlejobs.com)

Requisition ID: 77063961

It is our business imperative to remain a very inclusive workplace.

To our veterans and separated service members, you're at the forefront of our minds as we recruit top talent to join Nestle. The skills you've gained while serving our country, such as flexibility, agility, and leadership, are much like the skills that will make you successful in this role. In addition, with our commitment to an inclusive work environment, we recognize the exceptional engagement and innovation displayed by individuals with disabilities. Nestle seeks such skilled and qualified individuals to share our mission where you'll join a cohort of others who have chosen to call Nestle home.

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Job Requisition:365944