Quality Specialist - CMO
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
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Quality Specialist - CMOApply 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 – CMO.
Our Quality CMO team is accountable for oversight of Biologics product manufactured at CMOs on behalf of Takeda.
The scope includes Drug Substance, Drug product and Finished Drug Product CMOs.
The team will work with our external CMO partners and internal Quality teams. In addition, this function works closely with External Supply, Supply Planning, Technical support and any stakeholders involved in external supply.
- As our Quality Specialist, you will be our Quality contact for CMO(s) maintaining oversight at those CMOs for Quality related topics
- You will be our Quality representative on the External Supply team and will work collaboratively with the cross functional team and CMO to facilitate supply of product to our patients according to Takeda SOPs and GMP standards
- You will prepare for and attend relevant CMO governance meetings and internal Takeda meetings
- You will be required to resolves quality related topics and escalate where further input is required
- You will be our Quality contact/approver for Quality documents, for example, change controls, deviations, CAPAs, validation documents related to CMOs and you will be the Quality approver for CTL documents.
- You will maintain and improve CMO quality metrics that incorporate continuous improvement methodologies and where necessary, you will support internal audits and Health Authority inspections as required.
- You will review and approval of CMO documents
- Provide evaluation of CMO’s Quality Management Systems to ensure appropriate level and content of reporting, including technical evaluation of quality system reports
- You will work in collaboration with the Disposition team, Quality teams and cross functionally with external supply, planning, technical and other stakeholders including CMO partners.
Key skills required
- Thorough understanding of quality systems and cGMPs.
- Experience conducting audits and/or involvement in preparation for Health Authority inspections.
Education, Behavioural Competencies
- 6 years’ + experience working in manufacturing and/or Quality to support the manufacturing of biologic products.
- Strong technical/Quality background with specific experience in Biologics manufacture.
- Manufacturing site experience and CMO oversight experience would be valuable.
- Interpersonal skills and communication skills to interact with CMO partners and other functions.
- Must be able to prioritize in a busy environment.
- Must 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 SR0039026