Head Of Quality, Products DivisionClinigen • Shah Alam, Selangor, Malaysia
Head Of Quality, Products Division
Clinigen • Shah Alam, Selangor, Malaysia
2 days ago
Job descriptionActing as the main point of contact on all Quality matters for the Clinigen Products Division, internally and externally. To coordinate and lead (where applicable), Competent Authority inspections, Client audits and self-inspections. To manage authorised 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 Clinigen licences. To ensure that any additional requirements imposed on certain products by national law are adhered to. To perform due diligence checks and ensure suppliers and customers are qualified. Manage the quality release of batches and communicate with relevant Qualified Persons. 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 ensuring the approval of any subcontracted activities which may impact upon GxP. To follow, review and assist in the improvement of the QMS for the Clinigen Group 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 Ensure there is a system, procedures and program to manage the validation or qualification of premises, equipment, processes and computerized systems Support IT systems (including eQMS and ClinigenOne projects), ensuring the systems are rolled out on a site level in a compliant manner. Lead the delivery of operational excellence, working in partnership with the business areas to identify and implement improvement opportunities across the business processes to eliminate non-value add activity, create capacity and deliver benefit. Ensure the team uses the right continuous improvement methodologies, tools and thinking to support and embed a culture of continuous improvement. Support integration efforts across all Clinigen Group sites by working with the Head of Quality (Services) and Head of Quality (Shared Services and Process Governance), ensuring a consistent approach to quality across the Clinigen Group. Providing direction and guidance to the Quality team. 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 the 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. To follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures Perform other related job duties or responsibilities as assigned 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 the 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 Identify top talent and ensure there is a plan in place to retain them, keep them engaged and maximize their potential Recognize and celebrate success on a team and individual level Champion the Clinigen Way principles which underpin everything we do, living those values in daily Clinigen life Know Clinigen’s strategy and ensure what you do on a day to day basis is in line with those strategic objectives Ensure the work you do is of high quality and that Clinigen standards, procedures and policies are followed at all times Engage in personal professional development and attend mandatory training Present the Company in a positive way at all times with internal and external clients, customers and staff Comply with the Company’s HR policies and the Health and Safety policy at all times Work flexibly and efficiently in order to meet internal and external customer needs, whilst maintaining the highest possible professional standard Bring new ideas and approaches with an open mind Maintain confidentiality and security at all times Substantial experience within a Pharmaceutical industry Extensive knowledge and experience within Quality and GxP processes Strong leadership / team management skills and experience. Credible and confident communicator (written and verbal) at all levels. Strategic thinker with the ability to influence at a senior level. Customer focused & commercially astute. 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 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 Clinigen 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 Understand the business environment in which Clinigen Group operates Have an appreciation of the industry sector and current competitors in the market Understand the customer base and is aware of customer requirements Highly computer literate; experience operating with all Microsoft Office software Ability to operate office equipment (telephone, calculator, photocopier, fax, and scanning machines) Ensure all quality processes comply with local and relevant regulations. Collaborate with the Health & Safety team to integrate standards into operational procedures. Identify and mitigate potential safety hazards in quality control areas. A competitive monthly salary that reflects your experience, skills, and the industry standards, ensuring that you are fairly compensated for your hard work and dedication. A performance bonus designed to reward exceptional performance and achievements, providing you with additional financial incentives as you excel in your role. Generous annual leave of 20 days, allowing you the opportunity to take time off for rest, relaxation, and personal pursuits, promoting a healthy work-life balance. Ongoing professional development opportunities, including training programs, workshops, and access to resources that will help you enhance your skills and advance your career within our organization.
Clinigen is a distinguished global specialty pharmaceutical company that combines unique pharmaceutical and services businesses. We are dedicated to providing access to essential medicines that our customers need, regardless of their location in the world.
Position Summary
We are seeking a qualified and experienced Head of Quality for our Products Division. This pivotal leadership role entails ensuring that our division adheres to the highest quality standards and complies with relevant regulations and guidelines. You will be responsible for leading a team committed to excellence in quality assurance, quality control, and continuous improvement across our product offerings.
Leadership and Planning
- Developing and implementing the Quality department’s strategy to ensure compliance and efficient support to the Clinigen business, to ensure it meets the divisional requirements and customer deliverables, as well as ensuring the departmental performance against goals.
- Implementing and monitoring all Quality Assurance systems to ensure compliance with GxP regulations and guidelines.
- Harmonizes Quality Systems in line with Global Quality Management System.
- Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled in accordance with current requirements (EU GMP Part III Q9).
- High level resource planning.
Quality Operations
Quality Management System (QMS)
Operational Excellence
Personnel
People Management
General Responsibilities
Requirements
Health and Safety
Benefits
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Head Of Quality • Shah Alam, Selangor, Malaysia
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