QA Head

Description

QA Head ..C Contract ..C Switzerland or Shanghai based
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A multinational biotech organisation requires a QA Head for its International region for their existing biotech manufacturing facilities. You will implement and coordinate all non-GMP manufacturing Quality activities in the International Region. You will ensure appropriate issue escalation occurs related to any quality or compliance issues.
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The Role:
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*Management and oversight of all quality related activities within the International region.
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*Responsible for ensuring appropriate implementation and maintenance of Quality Systems in compliance with both regulatory requirements.
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*Operational responsibility for the vaccines non-manufacturing Quality units world wide
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*Coordinate activities related to the release and distribution of vaccine product in the International Region.
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*Disposition vaccine products and manage review and approval of transportation data.
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*Work with affiliates & 3rd party suppliers to ensure proper cold chain qualification.
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*Participate in distributor compliance audits, ensure follow up and oversight of CAPA!�¯s is occurring as outputs from audits.
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*Track CAPA/remediation plans stemming from audits (e.g. risk mitigation plan or CAPA!�¯s due to deviation) and ensure the progress on the actions defined.
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*Ensure warehouse and distribution facilities (sub-contracted) have been approved
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*Liaise between the Pharma and manufacturing sites regarding all quality issues and escalate potential product release delays to all key stakeholders.
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*Manage product recalls and withdrawals as necessary.
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Experience:
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*10+ years relevant experience in Pharmaceutical Industry e.g. Pharma production, QA operations or commercial distribution.
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*Experience of working with International Region countries
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*Experience with Vaccines and Biologics is essential
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*A strong understanding of Cold Chain Qualification and Validation processes is essential
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*Experience of working with 3rd party suppliers improving Quality
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*Experience of performing / leading investigations
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*Strong understanding of GMP/GDP requirements
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*Please note that this position can be based in Shanghai or Switzerland
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*The ability to speak Chinese will be highly desirable
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An outstanding daily rate is on offer alongside an exceptional opportunity to join a multinational biotech organisation
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