An industry leading commercial pharmaceuticals group with a network of global locations is looking to hire a Quality Operations Manager for their team in Drogheda. The role is a newly introduced and important position responsible for production operations and timely product batch release reporting into the Director of Quality Assurance.
As Quality Operations Manager you will lead a team to drive operational quality aspects and will be responsible for all quality assurance related to production processes. You will also act as the key point of contact with customers in relation to quality issues.
The business work across a wide range of dosage forms from non-sterile to biologics so you will gain experience in all product forms. The QA Director is committed to training the new Quality Operations Manager to become a subject matter expert across their entire product portfolio.
Key responsibilities as Quality Operations Manager:
- Manage the generation and review of all batch manufacturing records as part of production start-up and post batch review activities
- Partner with the Quality Systems Manager to optimise QA performance and drive continuous improvement.
- Review and approve deviations and investigations arising from the production process
- Maintain compliance with GMP and customer expectations as defined in Quality Agreements.
- Manage the activities of the quality operations team (currently 4 direct reports).
- Participate in regular meetings with customers to ensure current business needs are fulfilled and support continuous improvement projects including new product introductions.
- Lead customer audits as required
- Identify and support opportunities for improving internal processes and or procedures
- Become an area Subject Matter Expert on Quality matters relating to the process in order to assist in Customer and Regulatory audits as needed.
Key experience required:
- Demonstrable experience supporting manufacturing or packaging activities within the pharmaceutical or medical device industry.
- Experience in the review of deviation investigation and use of applicable investigation tools
- To have good knowledge of Quality Assurance inspection requirements.
- Good working knowledge of cGMP
- Continuous Improvement methodology
- Qualified to Degree level science or engineering or similar
As the business is a fast-paced contract pharmaceuticals group you will quickly be able to develop your commercial acumen with access to all areas of the organisation. The company works with the world's leading pharmas and biotechs so the role will provide regular contact with a global customer base. There is also scope within the role to become a Qualified Person for the group if you are QP eligible or soon to be eligible.
This is therefore an excellent opportunity if you want to develop and broaden your experience and will open up a wide range of career opportunities as you continue to grow in the pharmaceuticals industry.
A salary of up to €65,000 is on offer for the Quality Operations Manager with the potential to go higher for an ideal candidate.
This position is a key hire and the intention is to begin interviewing throughout January so please apply as soon as possible to be considered. You can also contact James Ivall at Goodman Masson on +44 2073 240 538 should you have any questions or want to discuss the role in more detail prior to applying.