Do you have a sterile manufacturing background and are you looking to make a move towards consultancy?
Are you looking to make a move into a Director level role with a growing company?
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 there is flexibility around remote working?
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 Sites Principal Consultant and will provide key support on all matters relating to the provision of services to their client and customer base.
The successful candidate will manage the activities of the project delivery team and associate consultant panel.
They will also oversee technical delivery and oversight of all projects and provide support to the Principal Consultant including:
- Project scoping, delivery, technical and budgetary activities
- Ensuring delivery in line with project commitments and client requirements.
- Co-ordination and oversight of the day-to-day activities of the project delivery team and the associate consultant panel
- Delivery of client related services and company projects within defined timelines and costings
- Delivery of all technical activities in line with applicable pharmaceutical regulatory requirements and standards
- Management/oversight of delivery of the project portfolio, from Expression of Interest (EoI) phase through to project close out, including development of project proposals, correct identification and allocation of project teams/project costings, creation and management oversight of project plans & implementation of project timelines. Liaison with clients to ensure satisfaction with services delivered.
- To keep abreast of changing regulatory standards, industry best practice and emerging trends to ensure competency of relevant personnel and consultant panel (as required and appropriate).
- Monitoring and controlling expenses and budgets.
- Provide support to the project delivery team for the monitoring and management of project budgets
- Deal with internal/external customer contacts and resolve queries and problems in an effective 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 EHS requirements.
- 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
- Former HPRA/MHRA Inspector preferable but not essential
- Minimum 15+ years' relevant experience in Steriles and/or Biologics or Good Distribution Practice (GDP).
- 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
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.