Ardern Healthcare Limited is a rapidly-growing global specialty medical and pharmaceutical company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The Group consists of five synergistic businesses focused in three areas of global medicine supply: clinical trial, unlicensed and licensed medicines. we provide patient access to our own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials.
ROLE
The role is responsible for ensuring that operations carried out within the Quality team in Ardern Healthcare Limited sites are completed in accordance with the requirements of the regulations and guidelines, Ardern Healthcare Limited Quality Systems and Industry Standards. This role will represent the Quality department on assigned project teams in order to provide a consistent approach to the formulation, preparation and execution of quality actions and to also ensure that these activities are implemented in a controlled manner in line with GxP and Ardern Healthcare Limited Global Quality expectations.
The key responsibilities for this role are:
Quality Operations:
To perform due diligence checks and ensure suppliers and customers are qualified
To manage authorized activities to ensure operations do not compromise the quality of medicines and can demonstrate relevant compliance
To demonstrate the application of activities and provisions in accordance with the Ardern Healthcare Limited licences
To ensure that any additional requirements imposed on certain products by national law are adhered to
Manage the Quality release of batches and communicate with relevant QPs
To ensure appropriate transport requirements and methods for time temperature sensitive medicinal products and hazardous products are used
To ensure transport equipment is appropriately qualified
Responsible for the approval of any subcontracted activities which may impact on GxP
Quality Management System (QMS):
To follow, review and assist in the improvement of the QMS for the Ardern Healthcare Limited
To ensure customer complaints are dealt with effectively
To coordinate and promptly action any recall operations for medicinal products and to cooperate with Marketing Authorisation Holders and Competent Authorities
To be aware of the issues surrounding falsified medicinal products
To manage the process of development, review and approval of Quality Technical Agreements.
Business Improvement
Able to practice continuous improvement and utilizes tools and techniques to solve problems
Ensure there is a system, procedures and program to manage the validation or qualification of premises, equipment, processes and computerized systems
Personnel
To manage Quality personnel, ensuring job descriptions, objectives, personal development plans and appraisals are up-to-date and completed on time
To ensure that Quality personnel are GxP trained and reflect the same within their duties
To maintain training records for self and Quality, to ensure training is assessed where required
Build and manage a high-performing, collaborative team that works in line with the Group’s values at all times.
Ensure the appropriate level of resource and expertise is in place and that this is structured in the most effective way to deliver the strategy.
Ensure that team have clear objectives in place and that they understand how these relate to the KPIs and the divisional and Group level strategy.
Ensure all team members have development plans in place and regularly reviewed.
Provide regular feedback to direct reports. Proactively address underperformance.
Ensure effective communication of key messages to the team from across the Group.
Recognize and celebrate success on a team and individual level.
REQUIREMENTS
The successful candidate will have the following:
Qualified Person status preferred
Substantial experience within a Pharmaceutical industry
Extensive knowledge and experience within Quality and GxP processes
Computer literate e.g. Word, Excel, PowerPoint, Visio
Ability to exercise autonomy, good technical and scientific judgment, within the responsibilities defined within this job description
Experience of developing and implementing operational plans for the areas of responsibility defined within this job description
Ability to interpret and translate GxP guidelines into effective business strategies and processes
Extensive people management experience
Project management skills and able to prioritise work plans and have an ability to perform multiple tasks at one time
Ability to initiate and maintain working relationships and communication links with the Ardern Healthcare Limited Group, affiliated organisations and third party contractors
Ability to put across ideas in a clear and concise manner and present a well-structured case to communicate complex information to others
Proactive, diplomatic, self-motivating, professional with good problem solving, decision making capabilities, influencing and negotiation skills
Advanced communication and presentation skills
Have an understanding of the business environment in which Ardern Healthcare Limited operates
Have an appreciation of the industry sector and current competitors in the market
Understand the customer base and is aware of customer requirements
