Do you have a sterile manufacturing background and are you looking to make a move towards consultancy?
Are you experienced with Auditing (both internal and external)?
Would you relish the opportunity to work as a PM on various interesting projects with external stakeholders?
Would you value working in a company where remote working is a possibility?
If so, I may have the role for you.
We are working with a leading global consultancy based in North Dublin to fill a number of new roles which have come about due to company growth.
The client specialises in providing expert knowledge in the areas of Development, Reg Affairs, Quality Management & Compliance and Pharmacovigilance as well as other areas.
They work with global pharma, biopharma companies across an array of product types.
This position will report into the Director/Senior Consultant and will provide key support to the Director/Senior Consultant in all matters relating to the provision of services to their client and customer base.
The role has 4-5 direct reports all of which are technical specialists.
The main focus areas for the role will be on technical delivery of client projects, both individually and through the management of their direct reports and will also include acting as a QP, GxP compliance audits.
- To liaise with customers with regard to their requirements, determining their needs and timelines and to manage client projects including the preparation of project proposals and the implementation of Project Plans including timelines and costings.
- To conduct Quality Audits for Customers in line with PharmaLex Ireland auditing procedures and in line with all Pharmaceutical Regulatory requirements and Standards, to highlight deficiencies to the customers and to support (as required) in the remedy of those deficiencies.
- To act as a QP.
- To advise and support companies in the establishment and improvement of their Quality Systems.
- To follow-up with existing customers to ensure satisfaction with service.
- Co-ordination and oversight of the day-to-day activities of direct reports
- Technical management of client projects ensuring the completeness of project plans, correct allocation & implementation of timelines and project costings. To ensure all personnel and Associates are aware of their responsibilities and to monitor progress against key milestones/activity dates and report on progress to the Director/Senior Consultant and Project Team.
- Prepare draft training material and co-deliver/deliver training to clients.
- To undertake ongoing Continuing Professional Development (CPD) - Keep abreast with changing Regulatory Standards, Industry Best Practice and emerging
- Deal with internal/external customer contacts and resolve queries and problems in an effective manner and timely manner.
- Liaise with Clients, regulatory authorities and other external parties as required/requested
- Ensure compliance with all company policies and procedures, including Quality Systems, and E, H&S requirements.
- To ensure all documentation prepared is in line with standards as set down by relevant Legal and Regulatory bodies.
Qualifications / Experience
- 3rd level qualification in Science or Quality Management
- 10 - 15 years' relevant experience in Steriles and/or Biologics
- Experience with ATMPs would be a distinct advantage
- Experience and interest in QA and compliance, ideally with hands-on experience in manufacturing - perhaps as part of a QA role. Can demonstrate exposure to & understanding of manufacturing processes * 10+ years in supervisory or management positions
- In-depth understanding of regulatory standards in pharmaceutical industry, and sources of regulatory information.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.