Consultant for GMP compliance and quality assurance in Life Sciences. Engage in validation projects and assist in compliance documentation.
About the role
- Senior Manager of IT GxP Compliance ensuring alignment across quality initiatives at Nestlé Health Science. Leading compliance programs and technology-driven strategies for regulatory excellence.
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 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.
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
- 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 resolution, 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
- Strong customer service orientation and an understanding of business processes related to pharmaceutical and dietary supplement manufacturing
- Occasional travel required, as needed.
Benefits
- Performance-based incentives
- Competitive total rewards package
- 401k with company match
- Healthcare coverage
- Benefits that support physical, financial, and emotional wellbeing
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