A start-up biologics manufacturer is looking to hire a Senior Quality Assurance Manager to lead Qualified Person related activities across the site manufacturing operation in Dublin. This would sit as part of the site management team with direct responsibility for a team of QP's.
The Senior Quality Assurance Manager will partner with all business functions to help steer the direction of the business and support a fast growth trajectory as they prepare to launch a milestone product later this year.
An excellent candidate for this role will have hands-on product release experience in an aseptic pharmaceuticals manufacturing environment. You will have some people management experience and be ready to step into a more senior leadership position.
As Senior Quality Assurance Manager, you would have responsibility for:
- Management of the Qualified Persons biologics team.
- Management of QP batch record review, batch disposition and material status control activities associated with the product.
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Assisting in the Change Control process, ensuring controlled implementation of all GMP related changes.
- Ensures the batch disposition process maintains compliance with site practices and regulatory requirements.
- Implementation of Key Performance Indicators within the QP team to align with company and global quality objectives.
- Participation in the site Internal Audit programme.
- Participation in the preparation of, and hosting, external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- Participation in the preparation of documentation for regulatory submission and participation in regulatory affairs discussions.
- Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
- Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
- Motivation, training, discipline and appraisal of QP team.
- Acting as a designee to the Head of Quality as required.
You will have the following experience:
- 3+ years of hands-on Qualified Person release experience in an aseptic pharmaceuticals manufacturing environment.
- People management either as a supervisor or line manager
- Proven operational experience at driving through QA projects from start to finish.
The salary on offer is €85,000 to €95,000 and can be higher for a candidate that brings very relevant experience. There is an excellent benefits package on offer also that includes, bonus, long-term incentives and more.
This Senior Quality Assurance Manager position is a critical hire to support the development of the group so interviews will begin within the next couple of weeks and CV shortlisting is already underway. Please apply by this advert or contact James Ivall at Goodman Masson as soon as possible if you would like to talk through the role in more detail prior to applying.
I hope to hear from you soon.