Reference Number: JO-2007-452485
Head of Quality and Qualified Person
Job Type: Permanent
Head of Quality and Qualified Person
Salary details available on discussion + excellent benefits package
My client is a leading biopharmaceutical organisation operating globally and specialising in a number of therapeutic areas including oncology cardiovascular, respiratory, rare diseases, infectious diseases and neurology.
Focussed on better outcomes to more patients faster, you would be part of an organisation that has been supporting patients within the UK for over 100 years. If you are looking for the opportunity to develop yourself, a team and a department then this could be just the role for you. With excellent development opportunities and the chance to be part of a top ten global biotech, now really is the time to get in contact to explore further.
The role will be responsible for leading an effective GXP quality function to ensure compliance with company procedural, regulatory and legislative requirements. Personally take on QP responsibilities and enable the GXP QMS through appropriate prioritisation, oversight and resource allocation as well as collaborating with local and global stakeholders and external stakeholders including the ABPI and MHRA to challenge and shape the UK Quality environment.
Other key responsibilities will include:
Input to development plans and programs to ensure appropriate Quality strategies are executed in accordance with the overall development plans;
Ensure good practices (GxP) are adopted and implemented throughout the organisation;
Maintain detailed working knowledge of the Quality environment through direct and indirect contact with agencies and industry groups including MHRA, EMA, FDA etc;
Work with staff, external stakeholders and advisors to ensure Quality compliance and take accountability for ensuring the company maintains its Inspection Ready status;
Provide Quality expertise and oversight internally to project teams and other departments;
Maintain a constant and current knowledge of global Quality intelligence, advising the business of any potential impacts with regards to changes in regulations and guidelines and recommending appropriate course of actions;
Prepare and manage the Quality annual budget;
Maintain and develop the QMS to ensure ongoing compliance with regulatory standards and regulations;
Delivering Quality training (GCP, GMP, GLP) to staff;
Managing QMS training for new and existing staff.
Manage annual External audit programme;
Manage internal audit programme including audit schedules;
Perform internal site audits;
Manage independent auditors;
Host regulatory authority inspections.
Ensuring compliance with GCP, GMP and other regulatory requirements;
Make sure that Quality systems support optimal day-to-day operations and projects;
Successful applicants must be able to demonstrate management experience as well as a strong understanding of pharmaceutical QA and GXP experience within a quality/pharmaceutical environment (10 years), Full QP qualification and batch release experience and ideally experience of both developing audit procedures, to include hosting and conducting across local and global regions.
You must also be able to show:
The ability to establish and maintain effective working relationships with internal and external stakeholders.
Extensive/demonstratable knowledge of GXP pharmaceutical procedures.
Demonstrated knowledge, understanding and application of GCP and GMP guidelines and regulations.
Full commercial QP certification and releasing experience
Fluent English communications skills (written & spoken).
Ability to interpret complex data and present key findings.
To apply for this role, please call Bob Beevers at Clinical Professionals on +44 07908 011 616 or send an updated version of your CV via email to firstname.lastname@example.org
If this role is not for you, we do operate a bonus referral scheme should we go on to successfully place someone that you recommend to us so please feel free to share these details within your network.