Pharmaceutical Consultant Manager
Location: Dublin, Ireland
to provide key support to the Director/Senior Consultant in all matters relating to the provision of services to our client and customer base.
To manage direct reports and to provide support to them for technical issues, training and development and HR issues.
The main focus areas for the role will be on technical deliver of client projects, both individually and through the management of their direct reports and will also include acting as a QP, GxP compliance audits.
Under the Guidance of the Senior Consultant:
- 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.
Manage the day to day activities of the direct reports as follows:
- Co-ordination and oversight of the day-to-day activities of direct reports in a manner to optimise billable hours
- Engage in the recruitment of staff
- Training new employees
- Coaching and developing existing employees.
- Dealing with performance problems and terminations
- Supporting problem resolution and decision-making.
- Conducting timely performance evaluations.
- Monitoring performance and initiating action to strengthen results.
- Monitoring and controlling expenses and budgets.
- 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.
- To prepare draft training material for external class-room based courses and for web based e-learning and downloadable training material.
- To co-deliver / deliver training to clients.
To undertake ongoing Continuing Professional Development (CPD) to ensure currency of technical knowledge and skills. This includes the development and maintenance of a Technical Reference Library at PharmaLex Ireland.
Business Development / Sales & Marketing
- To keep abreast with changing Regulatory Standards, Industry Best Practice and emerging trends to provide input to business development and product development opportunities.
- To follow-up with existing clients and potential new clients to increase client base and increase sales.
To prepare draft company publications including the Regulatory Update Bulletin and e-Newsletter, liaising with Associates, Industry personnel / sources to gain input and ideas for content.
To input as requested into the annual budgeting process.
- To deal with internal/external customer contacts and resolve queries and problems in an effective manner and timely manner.
- To liaise with Clients, regulatory authorities and other external parties as required / requested on behalf of clients and/ or on behalf of PharmaLex Ireland.
- To ensure compliance with all PharmaLex Ireland 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.
- 3rd Level Qualification in Science or Quality Management
- In excess of 15 years’ experience in GMP in sterile and biotech drug products.
- 15 yrs experience in Quality Assurance or Quality Compliance role.
- High level Computer Literacy and competency – Microsoft Office, Microsoft Project.
- QP StatusVendor Auditing Experience
- In-depth understanding of regulatory requirements applicable to the Pharmaceutical Industry, and knowledge of the sources of regulatory information (medical devices and cosmetics industries also considered).
- In-depth understanding of the purpose, objectives and scope of Quality Systems
- Effectively resolving compliance issues
- Working with third parties
- Creation of third party contracts / project agreements
- Working in cross-functional teams
- Contributing to company programmes or projects
- Managing change, influencing stakeholders and delivering results
- Strong Communication Skills – strong business English capability
- Strong technical writing skills
- Project Management Skills
- Strong Interpersonal Skills – when working with PharmaLex Ireland staff, Associates, clients and external 3rd parties
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
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