Director, Operational QA Network Management
vor 2 Monaten
Proclinical are partnering with a biotech organisation who are recruiting for an individual to join their team. This role is on a permanent basis. The opening position currently available is for a Director, operational QA Network Management.
Responsibilities:
You will lead by example and be a proactive and visible Quality Leader.Communicate and direct decision-making procedures for network partners in GMP query, which involves onboarding partners, new products execution and technology transfer.Assist the responsible persons for release as the first QA expert contact for quality events.The ideal candidate will serve as a quality representative of the company within both external and internal manufacturing networks as a marketing authorisation holder.Train and teach QA Managers to accomplish the next level and develop themselves as QA experts within the manufacturing and testing operations.Guarantee assessment of quality events and notification from the network's partners.Implement and ensure seamless communication t the company's business partners, CMOs and internal divisions to guarantee product release in a compliant and timely manner.Other duties may be assigned.Key Skills and Requirements:
Educated to a degree level in a life science, engineering or medical discipline.Know-how of pertinent US and EU guidelines, EMA, FDA and any other regulatory standards as well as GMP.Demonstrable experience within quality assurance, quality oversight or corresponding, preferably within a biotech or pharmaceutical organisation with respective knowledge.Familiarity with both external and internal contract manufacturing organisations, which involves expertise on CMO operations and release testing.Works well with others both internally and externally in a cross-functional matrix team, as well as abilities in shareholder management.Tactical and operational abilities with the capacity to make flexible but thorough decisions in a dynamic setting.A high attention to detail.Fluency in both German and English.Presentation and communication skills both verbally and in writing towards a varied audience.If you are having difficulty in applying or if you have any questions, please contact Josh Godden at j.godden@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
#QACompliance
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