Quality System Expert

Job Description

Takeda Neuchâtel

Site de Production Biotech | Biotech Manufacturing Site

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced...

Quality Systems Expert

Job Summary

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Systems team within a world-class Biotech manufacturing environment.

The Quality System Expert is responsible for supporting the Quality Systems group from a Subject Matter Expert (SME) standpoint in accordance with Takeda policies, standards, procedures and Global cGMP. The Quality Systems Expert insures that new or modified Quality Systems (deviations, change controls, quality risk management, complaints ...) are readily implemented on site and insures that existing systems conform to internal and external quality standards. He/She is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs. He/She provides quality oversight and quality assurance (QA) support to partners (QA, manufacturing, projects). He/She actively participates to internal and external inspections.

Main accountabilities

• Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
• Prepare oral and written communications and communicate problems to management with clarity and accuracy
• Ensures appropriate deployment and coordination with global and within the site of the Quality Systems
• Acts as Subject Matter Expert of one of the Quality Systems and support the others and he/she monitors his/her quality system performance for emerging trends and search for improvement opportunities.
• Acts as Quality approver as appropriate
• Support the preparation of the inspections including the pre-requested documentation, and contribute to the definition of the strategy of the observation answers, in their development, and plans for corrective and preventive action, and follow completion of CAPAs
• Participate to the audit team as appropriate
• Support the regular monitoring and the update of the Compliance Readiness Plan of the site with the different services
• Support the preparation and the analysis of the indicators related to the compliance activity and propose improvement actions in case of indicators showing underperformance
• Support Quality Assurance Experts and Quality Product Experts in bringing Compliance support or acts as Quality representative in projects.
• Provides Compliance coaching and training to partners
• Deliver training which he/she is in charge,
• Participate to the deployment of the QMS simplification/integration

Education and Experience

• Bachelor level degree in life technology fields (i.e. biotechnology, (bio)chemistry, engineering); advanced degree preferred
• 5+ years experience with at least 3 years with cGMP manufacturing, Quality, and Compliance and demonstrated use of Quality tools/methodologies
• Ability to understand aseptic manufacturing processes
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects (project management).
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• French and English level C1 or higher are a must

Working Environment

• Full time job, daily working hours Monday-Friday

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.