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 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.
(possible two days working from home)
- 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 the company 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.( not essential,QA experience necessary)
- 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 classroom 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 the company.
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 the company.
- To ensure compliance with all of the company's 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
- 9-10 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
- 5-8+ years in supervisory or management positions
Knowledge, Skills & Behaviours
- In-depth understanding of regulatory standards in pharmaceutical industry, and sources of regulatory information.
- Microsoft Office applications
- Project Management Skills
- Presentation, training and facilitation skills
- Strong interpersonal skills
- Extensive professional experience in industry or area of activity (Quality and Compliance); good network across industry and associations; complemented expert knowledge by additional fields of expertise incl. economical areas; drives solutions to complex problems or sophisticated tasks impacting firm success
- Ability to define strategic goals for the company
- Structured, analytical, systematic and independent way of working; Ability to adjust rapidly to new, unknown, challenging situations; full discretion to drive strategy and take action consistent with operating policies
- Provide consultation to specific subjects and to extensive business process reengineering activities and related to change management; Identify and manage up/cross selling opportunities; Ability to analyse and solve problems and to develop pragmatic solutions at higher level (e.g. company level)
- Ability to lead project teams, distribute work equally and according to team members strengths; advancement of processes or tools within the defined area of expertise; convincing others in difficult change management situations
- Ability to build, manage and maintain working relationships with clients, on client's Vice President level; ability to convey strategic goals of collaboration
- Strong communication and negotiation skills (written and verbally), proven capability to communicate critical issues and proposed solutions to senior management levels; ability to convey stakeholders even in critical or sensitive situations.
- Excellent skills in presentation; convincing and confident appearance