A leading pharmaceuticals business based near London are looking to hire a Quality Assurance Manager and Qualified Person to support the batch release process of sterile and biologics products that are developed and manufactured on-site.
This role would be a great step for either an experienced QA Manager/QP who is looking to gain experience in biologics, or a more junior eligible QP with a sterile/biologics batch release support background who is looking to step into management and a more senior QP role.
As Quality Assurance Manager you will be an active member of the Quality Assurance batch release team and be the subject matter expert for your area that will span a broad range of projects, processes, and drug products. You would hold specific oversight and responsibilities for key quality systems and processes and will also serve as a primary quality partner for other key functional areas. You will also support with project specific activity, including continuous improvement and operational excellence initiatives.
As Quality Assurance Manager, you will be responsible for:
- Final disposition and certification to ensure that the batch has been manufactured in accordance with the requirements of the Marketing Authorisation and guidelines of cGMP.
- Providing overall quality direction and oversight batch release operations.
- Coordinating and approving Product Quality Reviews including batch listing and deviation trend reports.
- Quality SME review and approval for regulatory submissions to ensure compliance with site and corporate procedures.
- Provision of QA Subject Matter Expertise for complex investigations and associated CAPAs, as required
- Inspection readiness activities and hosting of internal and external audits/inspections
- Metric reporting, monitoring and representing the Quality Assurance function at cross-functional meetings and external forums
If you have the following experience, you would be a great fit:
- Relevant experience working in the pharmaceutical industry in Quality Assurance with experience in onsite manufacturing
- Must satisfy the requirements as outlined in Directive 2001/83/EC to act as a Qualified Person
- Must have proven experience as a releasing Qualified Person
- Experience having managed or supervised QA staff
- Educated to degree level in a Scientific or related discipline
A salary of £85,000 – £95,000 is on offer dependent on the level of prior experience with an excellent benefits package and flexible working.
This position is a critical hire to support business growth so interviews will be taking place throughout February. If you are considering a move and this looks like it could right next step, then please apply as soon as possible to be considered for interview.
If you have any questions prior to applying, then you can also contact James Ivall at Goodman Masson to discuss further.