Quality Systems Senior Expert

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The primary responsibility of this role within the Quality organization is to ensure technical coordination of activities within the scope of Quality Systems Experts (LIMS, Labware, MoDa and QC systems). The role acts as referent for the Quality Systems Experts and acts as Administrator/Owner/Subject Matter Expert (SME) of assigned process(s) or system(s), ensuring compliance with Takeda policies, cGMP, and internal/external quality standards. This role provides user support, and collaborates with cross-functional teams to protect patient safety and meet business needs. The Quality Systems Senior Expert offers support to partners, including quality, manufacturing, and projects, and actively participates in internal and external inspections.

Technical coordination:

• Act as referent for Quality Systems Experts (LIMS, Labware, MoDa and QC systems).
• Plan and distribute workload to the Quality Systems Experts (LIMS, Labware, MoDa and QC systems), coach/support the team and help defining priorities.
• Provide feedback on projects and routine activities using proactive communication.
• Perform relevant escalation/communication of critical issues.

Site Initiatives and continuous Improvement:

• Collaborate with our Business partners on site, other Takeda sites or Global to implement changes and improvements of systems.
• Proactively assist our business partners in expressing their needs to provide an adapted solution.
• Lead or support site initiatives and continuous improvement projects.
• Participate in the research, analysis, selection, and implementation of new tools, technologies and/or services as they are applicable to Neuchâtel quality and business needs and ensure alignment with our local/global partners.

System Ownership and user support:

• Act as System/Process Owner or Administrator for the assigned process/system.
• Act as site point of contact for the assigned process/system.
• Assist end users with processes of systems and with resolution of issues, including training and coaching.
• Create and update documents within the scope of the group.
• Review and evaluate internal or external change requests according to procedures, GMP requirements and licenses. Follow and implement the activities associated to changes in area of responsibility. Act as record owner and/or quality approver, as appropriate.
• Assess the deviations in term of acceptability to standard procedures and regulatory requirements and manage deviations in area of responsibility. Support investigations and definition of related CAPA process in area of responsibility. Act as record owner and/or quality approver, as appropriate.

Compliance/Quality oversight:

• Acts as Quality Representative in both routine and Takeda facility projects to support the quality system deployment and application to meet the current Regulatory Requirements.
• Support for regulatory agency inspection and internal audits, closure of observations/audit items and regulatory submissions.
• Deploy Data Integrity on site through a strong collaboration with Global Teams and the other facilities.
• Support the Quality Systems Manager in routine activities, as assigned.

Critical / Key skills:

• Degree in pharmaceutical sciences, life sciences, or a related scientific discipline.
• Minimum 7 years of experience in the (bio)pharmaceutical industry, ideally in a multinational company.
• Minimum 5 years of experience in the administration of quality management or laboratory systems and, preferably, with business processes associated with automation and integration of testing and production systems.
• Familiarity with GMP and regulatory guidelines (e.g., FDA, EMA, ICH).
• Leadership experience, developing people and strength in managing projects and initiatives.
• Good understanding of manufacturing, laboratory testing and warehousing operations applicable to biological products.
• Good understanding of Good Data and Documentation Practices (GDDP) and Data Integrity principles.
• Experience in creating, reviewing, and revising Standard Operating Procedures (SOPs) and technical documents.
• Experience supporting regulatory inspections and audits.
• Familiarity with risk management tools and methodologies (e.g., FMEA, root cause analysis).
• Experience with validating quality systems and software.
• Experience with integrating quality systems with other enterprise platforms.

Language & IT Skills:

• Proficiency in French and English (minimum B2 level or equivalent).
• Proficiency in using electronic quality management and QC systems (e.g., Veeva Vault, TrackWise, LIMS, Labware MoDa, Empower).
• Proficiency in Microsoft Office tools, including Word, Excel, Power Point and SharePoint.
• Proficiency with data analysis and reporting tools, including Power BI.
• Understanding of database management (e.g., SQL) for querying and troubleshooting.

• Strong team player, willing and able to support, lead, coach and inspire other team members as needed to achieve project goals.
• Strong communication skills (written and verbal) with ability to effectively communicate at multiple levels in the organization.
• Ability to effectively manage multiple tasks, deadlines, and priorities in a fast-paced environment.
• Meticulous adherence to regulatory standards and quality policies.
• Strong project management skills and ability to lead small to large projects.
• Demonstrate an understanding of business concepts.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to leverage and/or engage others to accomplish projects.
• Ability to work autonomously and to lead project teams in a matrix organization.
• Ability to train end-users on systems and processes.
• Ability to perform trend analysis on quality data and metric.
• Ability to work with cross-functional teams (e.g. other quality functions, manufacturing, supply chain).
• Strong organizational and follow-up skills, as well as attention to detail.
• Ability to drive change and continuous improvement mindset.
• Good analytical skills and ability to simplify the complex.

Complexity and Problem Solving:

• Capability to troubleshoot quality-related issues and propose effective solutions.
• Ability to identify gaps or inconsistencies in quality systems or documentation compared to internal procedures and external regulations.
• Act as a back up of Quality Approver, specifically in document management, deviation/CAPA/change controls/complaint or risk management.

Internal and External Contacts:

• Collaborates with all site functions using the assigned Quality Management or Laboratory Systems.
• Collaborates with Global functions, Takeda sites or external partners for the integration or modification of new or existing processes or systems.
• Act as a key contact with Management in case of escalation or reporting.
• Act as key contact with external service providers, notably with software/hardware suppliers.

Other Job Requirements:

• Act as a back-up of the Quality Systems Manager.

CHE - Neuchatel

Employee

Regular

Full time