Hobson Prior are currently seeking an QA Compliance Manager to join a leading pharmaceutical organisation where you have the opportunity to work permanently or on a contract.

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

Job Responsibilities:

• Ensure the compliance to applicable EU and US GxP regulations by ensuring effective monitoring systems are developed, maintained and communicated.
• Monitor new European and US legislation or changes in regulations that may affect compliance, necessitating changes to company QMS documents in a timely way to ensure compliance and inspection readiness.
• In liaison with the Head of Regulatory Affairs and Head of Quality Assurance, establish and maintain annual training plans for the EU/US Drug Development Division and be responsible for the implementation and delivery of the training plans.
• Keep up to date with current European and US best practices and changes in legislation that may affect the way we conduct clinical trials and the data it generates and manage the development/coordination of appropriate internal training requirements.
• Deliver and coordinate the delivery of high-quality training materials to internal personnel in the management of key GCP and other GxP topics including how to reduce audit findings, serious breaches, urgent safety measures, risk assessments.
• Manage QMS training to ensure all staff are compliant with current regulations and provide regular status updates to the Head of QA, DDD management and the MD.
• Assistance in managing the company's QMS ensuring completeness and accuracy.
• Act as a process expert regarding maintenance of the QMS.

Key Skills:

• Ability to work in a team environment under time and resource pressures.
• Flexibility and the ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.
• Able to interact effectively at all levels within a global organisation, as well as with external partners and clients.
• Proactive approach, a self-starter with a can-do attitude and a willingness to get actively involved from the basics to strategy development.
• Must be meticulous and methodical, with the ability to review both data and procedures in detail and the ability to see the greater overall picture.
• Proficient computer skills in Word, Excel, PowerPoint, email and Internet.

Requirements:

• Ideally a MSc (or equivalent) in life sciences, nursing or a combination of education (BSc) and practical experience.
• Solid demonstrable GCP Compliance experience gained within a global contract research organisation (CRO), pharmaceutical or Biotechnology Company, particularly with experience working in a Japanese organisation would be preferred.
• Demonstrable QA experience and ideally further compliance experience in the industry sector and/or corporate compliance.
• Excellent administration skills and attention to detail.
• Strong written and spoken English.
• Excellent communication skills (verbal and written), organisation and time management skills.
• Solid experience of producing and delivering training programmes and workshops. Excellent presentation skills are essential.

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.