Quality Systems and Compliance
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Quality Systems and ComplianceApply Now
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as our Quality Specialist.
Our Quality Systems and Compliance team is responsible for Quality Systems and Compliance for Biologics product in Takeda’s external sites and external contract manufacturing and testing organisation for Drug Substance, Drug Product and Finished Drug product manufacturing.
This team will work with our external CMO /CTL partners and internal Quality teams.
In addition, this function works closely with Global Systems and Compliance, External Supply, Supply Planning, Technical support and other stakeholders involved in external supply.
- As our Quality Specialist you will be responsible for executing deliverables for Quality Systems and Compliance across global external supply including our CMO and CTL partners.
- You will deliver on Biologics external supply inspection readiness and execution. The scope of this role includes Takeda’s external Biologics locations and global CMOs /CTLs for inspections performed by both Health Authorities and business partners.
- You will be responsible for Quality Systems supporting external supply, deviation and change control systems, APQRs, Quality Council, risk mitigation and QTAs/intercompany agreements.
- You will be required to and be responsible for reporting and driving improvement processes for quality metrics that incorporate continuous improvement methodologies.
- The scope of this role spans Drug Substance, Drug Product, Finished Drug Product manufactured at multiple CMOs across the region
Key skills required
- You will have a strong technical/Quality background with specific experience in Biologics manufacture.
- Manufacturing site experience/CMO oversight experience would be valuable.
- You will have thorough knowledge of GMPs, Compliance and Quality Systems.
Education, Behavioural Competencies
- 6 years’ plus experience working in a manufacturing and/or Quality environment supporting the manufacturing of biologic products.
- Thorough understanding of quality systems and cGMPs.
- Experience in conducting audits and/or involvement in preparation for Health Authority inspections.
- Excellent interpersonal and communication skills to interact with CMO /CTL partners and other internal/external functions.
- You must be able to prioritise in a busy environment.
- Be available to travel -approx 20% (domestic and international)
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.
Job ID SR0039037