Hobson Prior are currently looking for a Director of Quality to join a fantastic CRO on a permanent basis located in Southampton. Our client is focused on getting a better comprehension on the reason behind why some people's lungs are not able to protect themselves.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this position, you will be accountable for organising product complaints, investigations, and product recalls which involves the notification and engagement with regulatory bodies when needed.
• Guarantee the quality function meets the budget, cost, effectiveness targets such as KPIs are aligned with business goals.
• Partake in project teams offering contributions on quality needs throughout product development and commercialisation.
• You will serve as a representative for quality operations on due diligence teams.
• When requested you will assist in all regulatory inspections correlated to contractors and suppliers that form part of the product supply chain.
• The ideal candidate will uphold the active substance registration connecting to the procurement and provision of active (drug) substance.
• Evaluate and sanction from a quality assurance / GMP standpoint, documentation from supply chain providers.
• Form and uphold quality technical agreements with crucial GMDP supply chain contractors and suppliers.
• Any other assigned duties.

Key Skills:

• Interpersonal abilities.
• Capable of handling individuals and deliver outcomes within a matrix setting.
• A self-discipline individual with the ability to work efficiently in remote settings.

Requirements:

• Educated to a degree level in a life science field or a similar qualification linked to pharmaceutical sciences or systems.
• IMP experience.
• At least 5 years of experience in an operational quality position connecting to IMP or commercial product supply chain/late-stage development/commercialisation.
• Acquaintance with the expectations of regulators and competent bodies for the execution and upkeep of quality oversight procedures for a virtual supply chain, oriented around vendor management and qualification.
• Comprehension of the principles of GMP and GDP as implemented to IMP and commercial product supply.
• Prior involvement in the needs for GCP in the implementation of clinical trials.
• Experience in auditing, preferably in a biologics and aseptic compounding / sterile manufacturing setting.
• Computer literacy in Microsoft Office, specifically Excel.

Apply now:

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.