Director Quality Management Drug Substance

LausanneFixe2018-11-29Non exigé / Non qualifié
Spring Life Sciences is looking for his client a

Director Quality Management Drug Substance

The Role:

• This position has primary responsibility for providing Quality leadership and oversight to ensure that operations for products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices and other applicable regulations of all CDMO and key suppliers of starting materials.
• He/she will have hands-on experience in managing third-parties' quality aspects for drug substance manufacturing (USP and DSP).

Responsibilities:

• Manage GMP quality oversight (qualification, approval, monitoring) of CDMO's and suppliers of starting materials by
* planning and executing vendor audits, including monitoring of CAPA progresses till completion,
* Negotiate, establish and maintain quality agreements
* Perform Gate Reviews for PPQ readiness
* On-site presence during critical activities (e.g. PPQ campaign, Tech Transfer, HA inspections)
* Define KQIs/KCIs, collect data for periodic management review to identify Risks and mitigate
* Ensure Inspection readiness of all DS Vendors
• Manage internal and external Change Controls, Deviations, Events, CAPAs, etc., related to starting materials and DS manufacturing (USP and DSP)
• Manage GMP compliance during Tech Transfer activities by reviewing, approving, as applicable, protocols, plans and reports (e.g. development, validation)
• Identify the risks and establish appropriate mitigation plan

Profile:

• A BA/BS, MA/MS or PhD in a scientific discipline or related field
• Minimum ten years' experience in a Quality function with increasing levels of responsibility in the biotech industry
• Strong understanding and interpretation of GMPs and best quality practices with regard to biotech manufacturing processes
• Experience with regulatory agencies such as the FDA, EMA, etc.
• Proven success in CMO management with clinical and commercial products

Votre contact

Life Sciences A151, répond à toutes vos questions au Tel. +41 58 233 4020.

Vous pouvez postuler directement en ligne.

Merci de préciser la référence JN -112018-294287 - HAID

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