Hamlyn Williams have partnered with an internationally recognized biopharmaceutical company who are going through a rapid phase of growth. The company specializes in the treatment of severe diseases with specific areas of focus within neurology and immunology disorders.

As a result of company growth, we are looking to fill a QA Manager position on a perm basis. This will be an independent role as part of a growing and dynamic quality assurance team, reporting directly to the Head of Biologics.

** English speaking role **

Responsibilities will inlcude:

• Approve all operational procedures/instructions specification & master production instruction with the potential to affect the quality of the product.
• Review & approve of validation protocol & reports, study protocol & reports to support Capital or key site projects as required 
• Making sure that there is stability data to support retest or expiry date, storage conditions
• Support inspections and audits from external parties (e.g. FDA, IMB, EMEA or alliance partners).
• Participating in internal audits as required
• Participate in the preparation/review of regulatory dossiers. 
• Establish and maintain support and key liaison representative with Third Party Managers
• Oversee key quality systems such as (CAPA /ER report system, Change Review Board system etc..)
• Ensure that all parts of the QMS are adequately resourced with competent personnel and suitable / sufficient premises and equipment.
• Ensure continued and adequate supplies to the market, such that the patient needs are covered and that any anticipated restriction in supply is escalated to the relevant competent authorities in a timely manner

Specific requirements for this position:

• Biologics background 
• QA experience-minimum of 5 years

Attach an updated CV to be considered