Quality Manager Artwork
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Quality Manager ArtworkApply 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 Manager Artwork.
As our successful Quality Manager Artwork, you will be responsible for providing Quality support/ oversight of artwork management/ labelling change process to ensure clear requirements are defined and executed to implement approved artwork/ components for production and eventual market release.
The scope of this role will span Artwork and Quality Systems supporting Finished Drug Product manufactured at multiple global CMOs.
- Quality oversight of the artwork management/labelling change process to ensure clear requirements are defined and executed to enable release of artwork.
- Quality Approval of the BOM change process for packaging BOMs
- Quality Approval of Changes and deviations related to Artwork, Labelling or finished packaging BOMs
- Supporting of gathering quality metrics and department activities as needed
- Support resolution on areas identified as non-conformance related to your area(s) of expertise
- Working in collaboration with the Artwork team, Quality teams and cross functionally with external supply, planning, technical and other stakeholders including CMO partners.
- Managing continuous improvement initiatives in the Quality processes supporting artwork and initiatives in Biologics external supply.
Key skills required
- You will have a strong technical/ Quality background with specific experience in Biologics manufacture and Quality Assurance.
- Manufacturing site experience would be valuable.
- Thorough understanding of quality systems and cGMPs.
- Knowledge & expertise in Artwork Management
- Quality approval of BOMs, change controls and deviations relating to artwork
- Experience conducting audits and/or involvement in preparation for Health Authority inspections.
Education, Behavioural Competencies
- 8 years plus experience working in manufacturing and/or Quality to support the manufacturing of biologic products and knowledge of artwork process.
- Interpersonal skills and communication skills to interact with Artwork, 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 SR0040225