IT GxP Compliance, Senior Manager

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.

The Senior Manager of IT GxP Compliance will shape and execute forward-thinking IT compliance strategies that leverage technology to drive quality and regulatory excellence. This role partners closely with Global Product Owners and Quality leaders to ensure alignment across critical initiatives. You will provide strategic oversight of GxP computer system validation and lead enterprise-wide IT compliance programs, ensuring adherence to Nestle Health Science policies, SOPs, and industry best practices. We are seeking a seasoned QA/Compliance professional who thrives as a trusted advisor and subject matter expert, influencing decisions and enabling a culture of compliance across the organization.

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

• Develop and lead a high-performing team of information technology professionals; fostering a culture of collaboration and support through coaching and mentoring; successfully translating business requirements into team deliverables, individual goals, and objectives.
• Collaborate with Quality Assurance, Information Technology, Legal and Compliance, Human Resources, Finance, Regulatory, Clinical, and other business functions, as well as relevant vendors, to ensure successful planning, execution, and delivery of IT compliance initiatives.
• Implement the IT Risk management process and program.
• Work independently to develop and execute validation protocols, such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in accordance with the validation master plan and other applicable standard operating procedures (SOPs).
• Review all validation plans, perform system validation, and create validation documentation, as necessary.
• Manage Application Service Providers (ASP) and Managed Service Providers (MSP) to support projects and compliance activities.
• Lead vendor audits and periodic system reviews, including user account reviews.
• Lead audit defense during internal or external audits or inspections.
• Collaborate with stakeholders and contractors to summarize validation results in final reports.
• Lead in efforts to continually improve the Computer System Validation (CSV) and Computer Software Assurance (CSA) program using compliant, efficient, and risk-based approaches.
• Manage the lifecycle of documents such as procedures, instructions, change control, and validation documentation within IT to ensure proper and timely review, approval, execution, and storage.
• Ensure activities and deliverables comply with both company quality assurance standards and applicable government regulations, such as FDA, ISO, and CSA guidelines.

Experience and Education Requirements

• BS degree in computer science, information technology or equivalent work experience.
• 10 + years of experience managing small, medium, or large internal/external teams in related IT areas.
• 10 years of experience in biotech, pharma, or life science is necessary.

Required and Preferred Skills

• In depth knowledge of pharmaceutical regulations including 21 CFR Part 11, Part 107, Part 210, Part 211, Part 820 and Part 111, ICH E6, EU GMP, GAMP 5, EU Annex 11
• Extensive experience in managing multiple validation projects, developing plans, managing project schedules, and directing vendor/contract resources in creating CSV deliverables.
• Diverse experience validating IT solutions for quality management, regulatory submissions, controlled document management solutions and clinical development.
• Strong experience managing global validation projects, teams, and resources. Must possess excellent communication, conflict resolutions, influence, and problem- solving skills.
• Deep understanding of the validation methodologies applied to on-prem system and SaaS environments.
• Experience with Box GxP, Veeva Vault (QMS, Quality Docs, RIM, Promomats), Benchling, Ellab, Kneat, BMRam, LabVantage)
• Strong attention to detail, quality oriented
• Must be self-motivated and comfortable in a fast-paced, demanding, and dynamic work environment.
• Bachelor's degree in computer science or related field with 10+ years of relevant experience
• 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 $169,000.00 to $190,000.00. 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.

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)

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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:377752