Head of Quality
il y a 3 semaines
**The Company**:
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.
**The Role**:
Due to continued growth, we are seeking a driven and strategic Head of Quality CSM (Clinical Supplies Management) to lead a high performing team of 29 across the US and Europe. As well as utilising your leadership abilities you will be accountable for ensuring operations are carried out within the Quality team across the Clinigen CSM sites are completed in accordance with the requirements of the GxP regulations and guidelines, Clinigen Quality Systems and Industry Standards.
You will represent the Quality department on assigned project teams 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 Clinigen Global Quality expectations.
**Key Responsibilities**:
- Follow, promote and enforce relevant SOPs, Job Aids, and Company policies and procedures
- Develop and implement the Quality department’s strategy for the CSM, to ensure it meets the divisional requirements and customer deliverables, as well as ensuring the departmental performance against goals.
- Implement and monitor all Quality Assurance systems to ensure compliance with GxP regulations and guidelines.
- Harmonize Quality Systems, to the extent feasible, with Regional, Divisional, and Global Quality.
- Implement and maintain a Quality Risk Management system to ensure risks are adequately controlled in accordance with current requirements (ICH Q9).
- High level resource planning.
**Quality Operations**:
- Act as the main point of contact on all Quality matters for Clinigen CSM, internally and externally.
- Coordinate and lead (where applicable), Competent Authority inspections, Client audits and self-inspections.
- Manage authorised activities to ensure operations do not compromise the quality of medicines and can demonstrate relevant compliance
- Ensure any additional requirements imposed on certain products by national law are adhered to.
- Perform due diligence checks and ensure suppliers and customers are qualified.
- Manage the quality release of batches and communicate with relevant Qualified Persons/releasing teams
- Ensure appropriate transport requirements and methods for time temperature sensitive medicinal products and hazardous products are used.
- Ensure transport equipment is appropriately qualified.
- Responsible for ensuring the approval of any subcontracted activities which may impact upon GxP.
**Quality Management System (QMS)**:
- Follow, review and assist in the improvement of the QMS for the Clinigen Group
- Ensure customer complaints are dealt with effectively
- Coordinate and promptly action any recall operations for medicinal products and to cooperate with Marketing Authorisation Holders and Competent Authorities
- 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.
**Requirements**:
- Substantial experience within the 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.
- 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 Clinigen Group, affiliated organisations and third-party contractors
-
Head of Quality and Regulatory Affairs
Il y a 4 mois
Brussels, Belgique Sasmar Pharmaceuticals Temps plein**Description**: SASMAR is currently seeking a highly skilled and experienced individual to join our team as the Head of Quality and Regulatory Affairs. With our headquarters based in Brussels, Belgium, and operations in Sydney, Hong Kong, Mumbai, Malta, London, and Chicago, we are a fast-growing pharmaceutical company that specializes in personal care and...
-
Head of Quality and Regulatory Affairs
Il y a 7 mois
Brussels, Belgique SASMAR Temps pleinSASMAR is currently seeking a highly skilled and experienced individual to join our team as the Head of Quality and Regulatory Affairs. With our headquarters based in Brussels, Belgium, and operations in Sydney, Hong Kong, Mumbai, Malta, London, and Chicago, we are a fast-growing pharmaceutical company that specializes in personal care and fertility...
-
Director of Operations
Il y a 7 mois
Brussels, Belgique Quality Seekers Temps plein**Company**: This hotel is part of a large and successful hotelchain. With locations in and around Brussels, all hotels are settled at strategic locations in the city. The hotel is positioned as one of the largest hotels in Brussels, not only in terms of rooms, but also in it's operations. In order to manage this we are looking for an experienced operations...
-
Head of Validation
il y a 1 semaine
Brussels, Belgique Elemed Temps plein**About the job** Title: Head of Validation Location: Liège, Belgium The company This company has been enhancing performance in healthcare across the world for over 150 years so have a huge amount of history behind it including being the first company to mass-produce dressings for wound care. Even though they have developed and manufactured many...
-
Head of Operations
il y a 6 jours
Brussels, Brussels, Belgique Wetlands International Temps pleinVacancy open for our new Head of OperationsVacancy open for our new Head of OperationsPublished on: October 10, 2024Wetlands International Europe is looking for a new Head of Operations to be responsible for the effective, efficient and high quality delivery and development of our projects and programmes while ensuring high standards in finance, project...
-
Head of Quality
il y a 6 jours
Brussels, Brussels, Belgique Clinigen Temps pleinThe Company:Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.We are currently 1,100 people headquartered in the UK...
-
Head of Ict System Cell
il y a 1 semaine
Brussels, Belgique Office of the Secretary-General of the European Schools Temps pleinOffice of the Secretary-General of the European Schools in Brussels We are seeking to appoint a Head of ICT System cell **Occupational category1**: 2.20 ICT Expert at the OSG (Full-time post - 37h30/week ) The European Schools are an intergovernmental organization providing a multilingual and multicultural education. There are currently thirteen...
-
Deputy Head of Kyc Operations
Il y a 7 mois
Brussels, Belgique ING Temps plein**Deputy Head of KYC Operations - Belgium**: *** Lead KYC II, KF19 - SuperCircle KYC - 50% work from home - Hiring Manager: Berkay Özlüdil - Recruiter: Sofie Van Den Bossche - One of your future colleagues: Lodewijk De Meester **A day in the life of a Deputy Head KYC Operations** - Together with the Head of KYC Operations, you are responsible for all KYC...
-
Head of Medical and Quality Belgium
Il y a 7 mois
Brussels, Belgique Amplifon Group Temps pleinAmplifon is an Italian multinational company and the global leader in hearing care solutions and services for retail expertise, customization, and consumer care. More than 20,000 professionals every day in a network more than 9,500 points of sale give back the joy of hearing, feeling, and living to thousands of people across the world.In Amplifon we believe...
-
Head of Engineering
Il y a 7 mois
Brussels, Belgique Activa Temps plein**Le poste**: As Head of Engineering, you will be responsible for overseeing all aspects of engineering projects relating to structural, piping, mechanical, and electrics/instrumentation/controls (EIC) in heat treatment furnace domain. You will lead a team of skilled engineers and designers, providing guidance, mentoring and support to ensure projects are...
-
Head of Controlling
il y a 2 jours
Brussels, Belgique Robert Half Belgium Temps pleinRobert Half Management Resources is currently looking for a **Head of Controlling ad interim **(M/F/x) for a 6 months assignment. Robert Half Management Resources is currently looking for a **Head of Controlling ad interim **(M/F/x) for a 6 months assignment. The company is based in Brussels region. As **Head of Controlling **ad interim**, you will be...
-
Head of Partnerships
il y a 19 heures
Brussels, Belgique ENAR Foundation Temps plein**Who we are** ENAR Foundation was established in 2009 by ENAR to solidify the funding base of the European anti-racist movement and to support innovative actions in support of building a racism-free Europe. In recent years, ENAR Foundation’s portfolio of activities has expanded such that it is time to establish ENAR Foundation’s first executive team...
-
Deputy Head of Project Management
Il y a 5 mois
Brussels, Belgique ICF Temps pleinDescription **Deputy Head of Project Management** ICF Next, one of Europe’s leading integrated communication agencies, is seeking a dynamic Deputy Head of Project Management to support the delivery of large-scale campaigns for clients across the European Union. In this critical leadership role, you will work closely with the Head of Project Management to...
-
Head of Department
il y a 4 semaines
Brussels, Belgique ICF Temps pleinDescription The Head of Department is responsible for the development and implementation of projects and services leading a team of up to 40 people. The department is a centre of expertise at ICF Next and responsible, notably, for (social) media relations, stakeholder engagement, paid media collaboration and influencer marketing on projects executed on...
-
Head of Quality Management
il y a 6 jours
Brussels, Brussels, Belgique Lufthansa Group Temps pleinLet your career take off!Responsibilities:Ensure highest safety, compliance and quality standards while driving innovation and fostering a culture of excellence across the team.Develop and enhance our Safety & Quality Management System.Conduct audits, manage risks, and ensure airworthiness standards.Safeguard the integrity and reliability of the airline's...
-
Head of Product Engineering
Il y a 7 mois
Brussels, Belgique Lity Temps pleinThis Belgian start-up focuses on innovative zero-waste yogurt concepts for hotels, organic stores, espresso bars, and healthy quick-service restaurants. Their goal is straightforward: to reinvent yogurt consumption for a more enjoyable, surprising, and, most importantly, sustainable experience. In an early-stage context, they are seeking their Head of...
-
Head of Finance
Il y a 7 mois
Brussels, Belgique T&G Europe - Belgium Temps pleinRequisition ID: 28700- Location: BRUXELLES, BE, 1000Welcome to **ENGIE Belgium**! Every day, we work together to develop efficient energy solutions to build a carbon neutral future! Engie Retail is focused on the sale of electricity & gas. Retail Belgium includes also several End-to-End entities (Senec, Cozie, ) focused on the sale of energy related...
-
Head of Finance
il y a 1 semaine
Brussels, Belgique ETUC Temps plein**Job vacancy at the ETUC - Head of Finance** The ETUC is recruiting a full-time **Head of Finance. **The Head of Finance is responsible for the ETUC finances and will report to the General Secretary. - **Permanent contract** on a full time basis**: - **Location: Brussels** **Description** - Oversee the financial activities of the organisation; - Forecast...
-
Head of Development
il y a 6 jours
Brussels, Brussels, Belgique Orange Cyberdefense Temps pleinOrange Cyberdefense, an Orange Group company, is one of the world's leading cyber security services and solutions providers.Orange Cyberdefense enjoys 25 years’ experience in the field of global information security, providing products and services for leading organisations in over 160 countries.We are building a safer digital society, protecting...
-
Head of PMO
il y a 6 jours
Brussels, Brussels, Belgique Page Executive Temps pleinCredit insurance company operating all over the worldA robust and dynamic company driving innovative transformation projectsAbout Our ClientOur client is an international credit insurance company.Job DescriptionYou will be Head of the Project Management Office (PMO). The PMO manages the business process management framework for the complete value chain and...