Head Of Quality Operations at Ardern Healthcare Limited

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 company consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines.

We are recruiting to fill the position below:

Job Position: Head Of Quality Operations
Job Location: Nationwide

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.

Key Responsibilities
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