Director of QA
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Hobson Prior are seeking for a Director of QA to join a brilliant biotech corporation on a permanent basis. Our client is focused on providing vaccines for seriously infectious illnesses.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will be responsible for documenting follow-up actions on audits / inspections and raise any local compliance matters as part of the Quality and Product Safety Management Board (Q&PSMB).
- Offer advice on compliance / regulatory needs and approaches for process & assay development and technology transfer actions.
- Guarantee compliance with regulatory needs for all advertising, product labelling and packaging.
- In collaboration with the functional heads at the company, you will set up and control the quality operations budget.
- To meet business requirements, the ideal candidate will recruit, guide, handle and evolve department personnel, offering them training, inspiration, and engagement.
- Serve as a representative for the organisation to external clients, authorities and service suppliers on all quality associated issues.
- Rendering to the licences risk management and pharmacovigilance systems, you will guarantee that systems and processes for the management of grievances and product recants are being directed.
- When fitting, you will sub-in as the line manager.
- To guarantee cross-functional and cross-site information and co-ordination, the ideal candidate will be accountable for affiliating with international functions.
- Warrant that JEV applicable measures, methods and assay are coordinated across all internal testing locations and external affiliates.
- Conduct tasks relevant to a Responsible Person's responsibilities on behalf of the company, rendering to the EU Directive 2013/C 343/01 needs.
- Any other assigned duties.
- Leadership proficiency with the ability to encourage and engross a productive team.
- Decision-making capabilities that associate with and imitate business requirements.
- Able to handle and prioritise multiple tasks.
- Capable of evaluating information in an organised way.
- Prior management experience in QA, Compliance, Quality Control and the manufacture of biopharmaceuticals preferably in vaccines within a pharmaceutical industry.
- Familiarity with EU and FDA cGMP and regulatory needs for the production, testing and licensure of biopharmaceutical products.
- Able to formulate comprehensible, clearly argued technical documents.
- Comprehension of the pharmaceutical business.
- QP-certification is preferable.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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