IT Compliance Expert - GxP

Nestlé Health Science; Brisbane (CA); Hybrid; USD 120,000 - 160,000; Full time

Job summary

An established industry player is seeking an IT Compliance Expert to ensure GxP systems are compliant and validated. This dynamic role involves collaborating with business stakeholders, managing IT GxP systems, and leading project implementations. You will be pivotal in maintaining regulatory compliance while driving improvements in system performance. If you have a strong background in IT compliance and project management within the biotech or pharmaceutical sectors, this is an exciting opportunity to make a significant impact in a forward-thinking environment.

Benefits

401k with company match

Healthcare coverage

Performance-based incentives

Broad range of benefits

Qualifications

• 7+ years of experience supporting enterprise GxP IT systems.
• Deep understanding of biotech/pharmaceutical manufacturing systems.

Responsibilities

• Partner with business to select and validate IT GxP Systems.
• Oversee application lifecycles for enterprise GxP IT systems.

Skills

IT Compliance

Project Management

Regulatory Compliance

Analytical Skills

Communication Skills

Education

BS degree in computer science

Equivalent work experience

Tools

Veeva

ServiceNow

SAS

DocuBridge

Tracelink

Job description

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Position Summary:

As an IT system owner, your primary responsibilities will revolve around supporting IT compliance of GxP systems and processes, partnering with business stakeholders to maintain validated GxP systems, and providing compliant business solutions. You will play a crucial role in the selection, development, validation, and maintenance of enterprise GxP systems, including Veeva, ServiceNow, Tracelink, Box GxP, SAS, PleaseReview, Veeva RIMS, DocuBridge, and supporting infrastructure.

In this position, you will have the opportunity to collaborate closely with business colleagues to define and document critical business processes and requirements. You will prioritize requests, create compelling business cases for technology solutions, and guide them through the IT governance process. By doing so, you will drive the planning, implementation, validation, and support of enterprise GxP applications.

Join our team and become part of a dynamic environment where you can make a significant impact on our IT compliance efforts and help shape the future of our GxP systems.

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 SOPs and Policies.
• Establish and drive governance processes that 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 a subject matter expert for the 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 lead a high-performing team of information technology professionals, fostering a culture of collaboration and support through coaching and mentoring.
• Successfully translate business requirements into team deliverables, individual goals, and objectives.
• Develop and measure IT support metrics and implement continuous improvement processes and procedures.
• Prepare operational forecasts and requirements, including monthly reports and budget analyses.
• 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.
• Perform other responsibilities as assigned or needed.
  
  

Experience and Education Requirements:

• BS degree in computer science, information technology, or equivalent work experience.
• 7+ 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.
• 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 Veeva RIMS, QMS, QDocs, SAS, PleaseReview, LabVantage LIMS, ServiceNow, DocuSign Part 11, Clinical Data Repository, Electronic Notebooks solutions highly desirable.
• 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 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.
  
  

The approximate pay range for this position is $120,000.00 to $160,000.00. Please note that the pay range provided 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.

Nestlé offers performance-based incentives and a competitive total rewards package, which includes a 401k with company match, healthcare coverage and a broad range of other benefits. Incentives and/or benefit packages may vary depending on the position. Learn more at About Us | Nestlé Careers (nestlejobs.com)

Requisition ID: 338596

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 Nestlé. 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. Nestlé seeks such skilled and qualified individuals to share our mission where you’ll join a cohort of others who have chosen to call Nestlé home.

The Nestlé Companies are equal employment opportunity employers. All applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status or any other characteristic protected by applicable law. Prior to the next step in the recruiting process, we welcome you to inform us confidentially if you may require any special accommodations in order to participate fully in our recruitment experience. Contact us at [e-mail] or please dial 711 and provide this number to the operator: 1-800-321-6467.

This position is not eligible for Visa Sponsorship.

Review our applicant privacy notice before applying at https://www.nestlejobs.com/privacy.

#Salaried

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Information Technology

• Industries

  Food and Beverage Services

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