Commercial Quality Lead, EUCAN
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Commercial Quality Lead, EUCANApply Now
- This role performs the quality oversight of selected EUCAN LOCs as assigned by the EUCAN CQ Head.
- Responsibilities cover in-country distribution quality, local quality surveillance and local contract manufacturing/packaging quality oversight for EUCAN LOCs/countries.
- This role drives the elevation of LOC quality capabilities and the advancement of the Takeda Quality Roadmap in the EUCAN LOCs
- Provide technical guidance & expertise to EUCAN LOC(s) on quality matters
- Drive timely resolution for quality matters in the EUCAN LOCs and escalation/communication within Takeda
- Manage initiatives to drive sustainability and compliance to Takeda QMS and local regulatory requirement in EUCAN LOCs.
- Drive the implementation and execution of quality improvement programs, risk management programs and compliance education initiatives in EUCAN LOCs.
- Lead regulatory surveillance & intelligence in region for new or emerging regulations.
- Identify areas of opportunities in the region for quality capability-building and lead the initiatives to strengthen the quality awareness and quality decision making.
- Drive the implementation of quality and compliance related continuous improvement initiatives and the implementation of best qualitypractices across the region.
- Provide guidance and drive the inspection readiness of EUCAN LOCs.
EDUCATION AND EXPERIENCE
- Scientific degree (BSc, MSc)
- >12 years of increasing management responsibility in the pharmaceutical industry including Quality Assurance, combined with a strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. cGMP/GDP, ISO and ICH requirements)
- Knowledge of global pharmaceutical operations, supply chain / distribution management, CMO management, Quality.
- Ability to work in an international environment cross functionally with remote teams and stakeholders. Experience include successful examples of managing and leading by influence - without direct resource control
- Previous regional quality experience &/or Commercial Quality experience is preferred.
- Fluent in written and spoken English.
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 SR0039733