Director, Quality and Compliance
Main purpose: Manage the activities of the project delivery team and associate consultant panel at PharmaLex, technical delivery and oversight of all PharmaLex 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.
- To manage the activities of the project delivery team and the associate consultant panel at PharmaLex including:
- Co-ordination and oversight of the day-to-day activities of the project delivery team and the associate consultant panel, both client and PharmaLex related, in a manner to optimise billable hours
- Delivery of client related services and PharmaLex projects within defined timelines and costings
- Delivery of all technical activities in line with applicable pharmaceutical regulatory requirements and standards
- Identification and follow-through of opportunities for upselling the services of PharmaLex
- To participate in service/ product development and business development activities as requested by the Principal Consultant or Management Team.
- Management/oversight of delivery of the PharmaLex 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).
- To undertake own ongoing Continuing Professional Development (CPD) to ensure currency of technical knowledge and skills.
- To participate in the evaluation process for potential Associate Consultants.
Manage the day to day activities of the project delivery team as follows:
- Co-ordination and oversight of the day-to-day activities of project delivery team.
- Project delivery in line with client budget and PharmaLex budgetary targets.
- Engage in the recruitment of staff.
- Training new employees.
- Coaching and developing existing employees.
- Participation in employee performance programme.
- Supporting problem resolution and decision-making.
- Conducting timely performance evaluations.
- Monitoring performance and initiating action to strengthen results.
- Monitoring and controlling expenses and budgets.
- To provide support to the project delivery team for the monitoring and management of project budgets
- To deal with internal/external customer contacts and resolve queries and problems in an effective 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.
- To support the project managers and technical team in ensuring customer satisfaction.
- To provide input to business development and service/ product development opportunities.
- In association with the Business Development team, to follow-up with existing clients and potential new clients to increase the client base and increase sales.
- To manage the technical inputs into company publications.
- To input as requested into the annual budgeting process.
- To provide support and input into the preparation of project budgets
- To ensure compliance with all PharmaLex company policies and procedures, including Quality Systems, and EHS 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
- Former HPRA/MHRA Inspector preferable but not essential
- Minimum 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.
- Microsoft Office applications.
- Project Management Skills
- Presentation, training and facilitation skills.
- Strong interpersonal skills
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.
Agencies only by prior agreement for the specific job opportunity.