Head Qualified Person
Slough, United Kingdom
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
Lonza has a great opportunity for an experienced Head QP (Qualified Person) to join our Quality Organisation. This is a permanent position based out of our state of the art development and manufacturing facility in Slough, UK
As the Head QP on site you will undertake the duties of a Qualified Person as defined in Directives 2001/83/EC as amended and 2001/20/EC. As such you will be responsible for review of relevant documentation associated with the manufacture and testing of Drug Substance and Drug Product Intermediates. You will also be responsible for the QP certification of Drug Product Intermediates in accordance with UK Code of Conduct for Qualified Persons. As well as being responsible for recording batches released in the QP Register.
- Directly managing the QP team, while ensuring that all QPs have gained the relevant knowledge and experience to certify a batch of a product type with which they are unfamiliar.
- Co-ordination of QP batch release activities
- To identify Lonza Slough talent who may be trained in house as QPs, ensuring a “steady” stream of QP supply for the business.
- Mentoring trainee QPs from acceptance onto a Lonza trainee “program” to attainment of full QP status and naming on the licence.
- Ensure that continual professional development (CPD) is maintained to allow the QP to effectively undertaken their statutory duties.
- Maintain up to date knowledge of all current and proposed regulatory, GMP and quality system elements.
- Ensure that all processes and procedures that are required for QP certification / batch release of drug substance are fit for purpose.
- Utilising knowledge of GMP and quality processes to advise non-QA functions on compliance issues via interaction with the relevant personnel
- Apply cGMP regulations consistently. Expand compliance knowledge base and mentor others to expand on-site compliance knowledge.
- Utilising knowledge of GMP and quality processes to actively identify, suggest and participate in continuous improvement activities within the QA (Operations) group
- Act as an ambassador for Lonza and QA in all interactions with customers
- Registered QP preferably having been named on a UK licence.
- Minimum BSc (or equivalent) in Biology, Chemistry, Pharmacy or any field recognized by the joint professional bodies.
- Extensive knowledge of EU/MHRA and FDA regulatory environments.
- Significant experience of QP release in biologics manufacturing or sterile manufacturing environments.
- Experience of releasing clinical batches would be advantageous
- Extensive experience of managing and developing a team.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.