Quality Compliance Lead
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Quality Compliance LeadApply 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 Compliance Lead.
As our successful Quality Compliance Lead you will be required to lead and coordinate all activities related to inspections at Takeda external Biologics locations and Takeda support for inspections at our CMOs and CTLs.
You will be responsible for hosting inspections at the Takeda locations and identification and involvement of co-hosts and SMEs depending on the scope of the inspection.
You will be responsible for maintaining site licenses and site master files and will be responsible for the Quality Council for Biologics external supply.
- Responsible for hosting external Biologics inspections at Takeda external supply locations and identifying co-hosts according to the inspection scope.
- Responsible for inspection readiness activities at CMOs and CTLs, including reporting and escalating inspection risks along with development and execution of actions focused on risk mitigation. This includes identification of interim controls and influencing stakeholders to drive timely action where mitigation is required.
- Maintains and demonstrates inspection readiness and partners with compliance to drive improvement to the inspection programs in alignment with Centre Function and CMOs/CTLs.
- Responsible for maintaining site licenses, renewals and inspection documentation
- Responsible for the Site Master Files including working with responsible groups to complete updates in accordance with procedural requirements.
- Manage Quality Council for external supply
- Responsible for inspection responses within defined regulatory timelines and generation of the associated CAPA plans
Key skills required
- Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC Guidance Documents and other Regulations.
- Demonstrated knowledge in biologic and aseptic manufacturing, systems and process technologies with strong regulatory and cGMP background for drug substance and drug product manufacturing.
- Management/leadership in operations and/or manufacturing in biopharmaceutical/pharma industry
- This role requires a significant wide-spectrum understanding of pharmaceutical manufacturing and the associated requirements. You will be required to work cross functionally and engage with internal and external stakeholders.
Education, Behavioural Competencies
- A Degree in a scientific/technical discipline
- Minimum 8 years’ experience in Q Systems/Compliance in Biologics/sterile manufacturing environment and industry managerial experience within manufacturing/Quality.
- 8 years’ plus experience in leading and managing highly effective technical, manufacturing or Quality teams and developing people in Q Systems or compliance teams.
- Experience in a multinational organization effectively navigating differing regional expectations and regulations
- Experience interfacing with regulatory bodies
- Recognise the importance of meeting patient, compliance and business needs
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 SR0039033