Digital Quality Applications Manager (TrackWise)
hace 10 días
Vigo
In a few words: Position: Digital Quality Applications Manager (TrackWise) Location: Madrid (On site) Experience: Minimum 7 years’ experience managing and supporting TrackWise Digital System (or similar) in a global, multi-site environment. 🚀 Ready to lead the future of Quality? Insud Pharma is hiring a Digital Quality Applications Manager (TrackWise)to drive our digital transformation journey across a truly global Quality organization. 🌍 About the role: Ready to be a #Challenger? The Digital Quality Applications Manager will be the central authority responsible for the strategic direction, successful implementation, ongoing administration, and continuous optimization of our enterprise-wide TrackWise Digital Quality Management System (QMS). This critical role will ensure that TrackWise Digital effectively supports our global quality processes, maintains stringent regulatory compliance (e.g., GxP), and drives operational efficiency and proactive quality management across all our sites. The candidate will possess deep expertise in TrackWise Digital, a strong background in quality processes, robust IT system management skills, and a proven ability to lead complex global projects in a highly regulated environment. Digital Quality Applications Manager (LIMS) is responsible for: Strategic Leadership & Roadmap: • Develop and execute a global TrackWise Digital strategy and roadmap that aligns with the company's overall quality objectives, digital transformation initiatives, and IT architecture. Identify opportunities for leveraging TrackWise Digital's advanced features, including AI-augmented capabilities, to enhance quality processes. System Ownership & Administration: • Serve as the global system owner for TrackWise Digital, overseeing its full lifecycle management., • Manage the day-to-day administration, configuration, and maintenance of the TrackWise Digital platform. This includes managing workflows, forms, fields, roles, permissions, reporting, and integrations., • Provide expert-level support, advanced troubleshooting, and timely resolution for all TrackWise Digital related issues, serving as a global escalation point., • Collaborate with IT infrastructure and cybersecurity teams to ensure system performance, data security, and adherence to corporate IT policies. Implementation & Enhancement: • Lead and manage new TrackWise Digital module implementations, significant upgrades, and strategic enhancements across global sites. This includes requirements gathering, system design, configuration, testing, validation, and change management. Regulatory Compliance & Validation: • Ensure that the TrackWise Digital system and its associated processes are fully compliant with relevant global regulatory requirements (e.g., FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, ISO standards)., • Oversee and actively participate in all computer system validation (CSV) activities for TrackWise Digital, including authoring and executing validation plans, IQ, OQ, and PQ protocols, and generating comprehensive validation reports., • Maintain meticulous documentation for all system configurations, changes, and validation records, ensuring audit readiness at all times. Data Integrity & Integration: • Ensure the integrity, accuracy, and traceability of all quality data within TrackWise Digital., • Design, implement, and manage seamless integrations between TrackWise Digital and other critical enterprise systems (e.g., ERP, LIMS) to enable end-to-end digital quality processes and data flow., • Oversee data migration strategies and execution as needed. User Training & Adoption: • Develop and deliver comprehensive, engaging training programs for TrackWise Digital users at all levels across global functions. Drive user adoption through effective communication, support, and promotion of best practices., • Process Optimization & Continuous Improvement:, • Partner with Quality, Operations, and R&D teams to analyze current quality processes, identify inefficiencies, and leverage TrackWise Digital capabilities for process automation, standardization, and continuous improvement globally. Vendor Management: • Act as the primary liaison with Sparta Systems (Honeywell) and other third-party vendors for TrackWise Digital support, new feature requests, and professional services. Manage vendor relationships and service level agreements. Team Leadership (if applicable): • Recruit, lead, mentor, and develop a team of TrackWise Digital admins, fostering a high-performing and collaborative team culture. Electronic Signature System Management: • Manage and optimize the electronic signature system., • Ensure system configuration, performance, and user support meet global operational needs., • Collaborate with IT and Quality Operations to ensure system alignment, upgrades, and new deployments. What do you need? • Education: Bachelor's degree in Computer Science, Information Technology, Chemistry, Biology, or a related scientific/engineering field. Master's degree preferred., • Languages: Fluent Spanish, English, knowledge of other languages will be an asset., • Experience (years/area): Minimum of 7-10 years of experience managing and supporting TrackWise Digital System in a global, multi-site environment., • Specific Knowledge: Proven experience leading multiple full lifecycle implementations or major upgrade projects of enterprise-level QMS systems in a global, multi-site environment. In-depth understanding of quality management principles and processes (CAPA, Deviations, Change Control, Audit Management, Document Management, Training Management, Complaints, Supplier Quality) in a regulated industry. Extensive experience working within a GxP-regulated environment (e.g., Pharmaceutical, Biotech, Medical Device) with a strong command of FDA 21 CFR Part 11, EU GMP Annex 11, and ISO standards (e.g., ISO 9001, ISO 13485).Demonstrated expertise in Computer System Validation (CSV), including authoring and executing validation documentation (URS, FS, DS, IQ, OQ, PQ) and maintaining a validated state.Expert-level knowledge of TrackWise Digital configuration, including workflows, forms, states, activities, security, and reporting.Experience with Salesforce platform capabilities as TrackWise Digital is built on it (e.g., Salesforce Administrator certification is a strong plus).Strong understanding of integration methods (APIs, web services) for connecting TrackWise Digital with other enterprise systems.Proficiency in data analysis and reporting tools; experience with TrackWise Digital reporting capabilities and dashboards.Familiarity with AI concepts in the context of QMS is a plus., • Travels: about 20% of the time, though this percentage may be increased., • Personal skills: Strong project management skills with the ability to manage multiple priorities simultaneously. Strong analytical and problem-solving abilities. Exceptional communication, interpersonal, and presentation skills with the ability to interact effectively with all levels of the organization and external stakeholders. Ability to work independently and collaboratively in a global team environment. Strong attention to detail and commitment to quality., • Preferred Qualifications: Project Management (PMP)training. Experience introducing emerging technologies (AI, data analytics) in the Quality space. Familiarity with agile working methodologies and digital transformation frameworks. 👩💻👨💻 Why Join Us? • Play a critical role in shaping the future of Quality at a leading global pharmaceutical company., • Lead cutting-edge digital initiatives that impact healthcare worldwide., • Work with diverse, passionate teams across continents., • Access outstanding opportunities for growth and professional development., • Make a real impact on patient lives around the globe. ✨ Join us at Insud Pharma and be part of a company where innovation, purpose, and excellence drive everything we do. Let’s shape the future of healthcare together. What will the Selection process be like? ➡Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels. ➡Prepare well! We will continue with an in-person/virtual interview depending on availability and what we agree upon; there may be one or two interviews in the process, and depending on the type of process, there may also be some kind of test. ➡Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process. COMMITMENT TO EQUAL OPPORTUNITIES Insud Pharma is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.
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