Senior Local Compliance Specialist
il y a 1 semaine
We are looking for a driven Senior Local Compliance Specialist to join our Clinical Operations team in Belgium and The Netherlands but also supporting the local compliance team in The Nordics (Sweden, Denmark and Finland).
You will contribute to a coordinated and comprehensive local quality and compliance approach to ensure our clinical trials will be delivered to the highest quality standards and are following all applicable SOP's, laws and regulations.
Our new colleague should be flexible, persistent and able to work independently.We are seeking to hire a strong communicator, a team player and someone with analytical skills, with quick learning and problem-solving abilities.
The Compliance Specialist will collaborate with the Compliance Managers, the Country Head, the Clinical Research Managers and the local teams in the whole Northern European cluster, carrying out the clinical trials, consisting of Local Trial Managers (LTM), Site Managers (SM) and Clinical Trial Assistants (CTA).
You will be part of a hardworking, enthusiastic, and committed team of +/- 215 people eager to deliver and helping to improve the lives of millions of patients.
Principal Responsibilities:
- Quality and
Compliance Oversight:
Proactively monitor compliance risks and metrics and install timely mitigation actions; Take ownership in implementing local quality plans; Perform on-site compliance monitoring visits, supervise progress and confirm efficiency of remediation plans and conduct QC checks on trials and processes; lead preparation and oversight of inspections and audits and timely implementation of CAPA's; leads or provides input in process improvement initiatives.
Takes ownership in writing business processes and/or Standard Operating Procedures- Onboarding and consultation: support onboarding of new hires; coordinate workshops, trainings and lessons learned on local and Northern European cluster level to increase compliance awareness. Be the goto person for risk management and provide advice for complex situations to ensure timely resolution of issues.
- Local regulatory intelligence: perform impact assessments of new/revised local regulations in countries within the Northern European cluster and provide clear and timely guidance to the teams. Keep local intelligence up to date.
- Collaboration with business quality: support in local supplier assessments; assist with annual due diligence update, certification and training of local suppliers.
- Cohost local compliance meetings in the Northern European cluster.
- Assume additional responsibilities or special initiatives such as 'Champion', ''Subject Matter Expert' or 'Business Process Owner', for local and cluster processes.
Qualifications:
Education and Experience Requirements:
- BA/BS degree in Life Sciences or related scientific field (or 46 years equivalent experience)
- A minimum of 3 years of previous pharmaceutical industry experience is required with at least 2 years of GxP experience within clinical research and/or quality assurance. Other relevant working experiences and skills may be considered by the hiring manager. Experience in phase 1, 2, 3 clinical trials is a plus.
- Good working knowledge and confirmed understanding of GCP, local laws, and regulations
- Developed knowledge of business processes and practices
- Ability to present in a clear and concise way strong communication skills
- Strong interpersonal and negotiation skills and ability to empower colleagues and stakeholders
- Proven project management skills
- Real diplomate that can understand impact and complexity of the situation, with the ability to create winwin situations
- Willingness to engage with Authorities and key site staff
About Johnson & Johnson:
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
-
Compliance Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique Manuchar Temps pleinThe JobYou will take on a critical role in providing compliance support to our global trading and distribution activities. In close collaboration with your team and other departments, you will support the further growth of Manuchar, by managing the regulatory risks in the many countries where Manuchar is active.Your main responsibilities are: You support the...
-
Acheteur Local Senior
il y a 7 jours
Antwerpen, Flandre, Belgique PaHRtners Temps pleinLe Groupe APERAM, 7ème producteur d'acier inoxydable au monde, est une **entreprise durable qui occupe une position de leader sur les marchés de niche à haute valeur ajoutée.** Le Groupe défend les valeurs **d'agilité, de leadership et d'ingéniosité**. Aperam Châtelet, qui dispose d'une Aciérie électrique et d'un Laminoir à chaud, est au centre...
-
Local Marketing Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique Unique Temps plein**Omschrijving**:Voor een overkoepelende speler achter verschillende foodketens, kijken wij uit naar een ervaren Local Marketing Specialist. Binnen deze functie zal je instaan voor het uitrollen van marketingcampagnes, - strategieën en -initiatieven. Heb je al ervaring binnen marketing en communicatie op zak? Én heb je een grote interesse in de...
-
Local Medical Safety Process Head
il y a 1 semaine
Antwerpen, Flandre, Belgique Johnson & Johnson Temps pleinRemote work options may be considered on a case-by-case basis and if approved by the Company._In this position, you will: Oversee and drive the LMS (Local Medical Safety) process strategy including Business owner and approval structure in Local Medical Safety and the creation and sunsetting of processes. Serves as a member of the LMS Operations Leadership...
-
Specialist Customs Compliance
il y a 1 semaine
Antwerpen, Flandre, Belgique H Temps plein7500 REASONS TO CHOOSE H.ESSERSH.Essers is an international and reliable family business that has been providing jobs and job security in the logistics sector since 1928. Our 7,500 ambitious colleagues dare to undertake, are ready to seize opportunities and make a difference every day with simplicity. This allows us as a company to continuously invest in...
-
Senior Quality Assurance Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique Oxford Global Resources Temps plein**Senior Quality Assurance Specialist - System Qualification**:- Location:Antwerp, Belgium- Contact:Dardo Helpers- Job type:Contract- Contact phone: - Industry:PharmaceuticalAls ervaren persoon binnen QA ben jij actief als specialist in de farmaceutische QA systemen. Je komt in een gestructureerd intarnationaal team terecht binnen big pharma om het...
-
Product Compliance
il y a 7 jours
Antwerpen, Flandre, Belgique Atlas Copco Temps plein.fit_to_content{width:%;height:auto}Passionate people create exceptional thingsDid you know that the solutions we develop are a key part of most industries?We ́re everywhere Working with us means that you can make an impact towards a sustainable future.Here, your ideas are embraced, you never stop learning, and you can be part of the solution for a better...
-
Compliance Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique Michael Page Temps pleinASSET MANAGEMENT - COMPLIANCE - AML - REGULATORY - UHNWI - ANTWERPStay vigilant on regulatory shifts, evaluating their repercussions on current business methodologies.Direct the execution of projects, initiatives, procedures, and measures in response to the fluid legal and sectoral environment.Execute thorough compliance assessments and effectively...
-
Senior Compliance Expert Dpo
il y a 1 semaine
Antwerpen, Flandre, Belgique 3D-ICT Temps pleinIntroductie**Senior Compliance Expert DPO**Heb jij een passie voor privacy? Kan jij je expertise als geen ander overbrengen dankzij je sterke communicatie en je oplossingsgerichtheid? Dan ben jij de geknipte persoon om als deputy data protection officer mee de privacy van onze klanten te vrijwaren.- Als deputy data protection officer ondersteun en challenge...
-
Senior Financial Controller
il y a 1 semaine
Antwerpen, Flandre, Belgique Katoen Natie Temps pleinJob description As Senior Financial Controller, you will be the driving force behind Katoen Natie's financial success in the assigned regions. You play a crucial role in the financial monitoring process, while you will also perform daily financial tasks; collaborating closely with local teams and reporting to the Business Unit Controller. Your key...
-
Senior Financial Controller
il y a 1 semaine
Antwerpen, Flandre, Belgique Katoen Natie Temps pleinJob description As Senior Financial Controller, you will be the driving force behind Katoen Natie's financial success in the assigned regions. You play a crucial role in the financial monitoring process, while you will also perform daily financial tasks; collaborating closely with local teams and reporting to the Business Unit Controller.Your key...
-
Senior Quality Assurance Specialist
il y a 7 jours
Antwerpen, Flandre, Belgique Oxford Global Resources Temps pleinLocation:Antwerp, Belgium- Contact:Dardo Helpers- Job type:Contract- Contact phone: - Industry:PharmaceuticalAls ervaren persoon binnen QA ben jij actief als specialist in de farmaceutische QA systemen. Je komt in een gestructureerd intarnationaal team terecht binnen big pharma om het kwaliteitsbeleid mee te sturen.**Job omschrijving**De Senior Quality...
-
Legal & Compliance Specialist in Asset Management
il y a 1 semaine
Antwerpen, Flandre, Belgique Ethias Temps pleinKom bij Ethias werken alsLegal & Compliance Specialist in Asset ManagementLiège - Liège/HasseltWij bieden jouVeel variatieSamenwerking met verschillende teamsFlexibiliteitJij biedtEnthousiasmeProactiviteitRelevante werkervaringJij kiest voor Ethias, voorHet warme teamgevoelDe uitdagingen en interessante projectenDe mogelijkheid tot directe impactEen blik...
-
Senior Workday Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique Coolblue Temps pleinTaken en verantwoordelijkhedenSamen met je collega's design, configureer en implementeer je Workday als nieuw HCM systeem. Wat doe je als Senior Workday Specialist bij Coolblue? Doe jij niets liever dan uitzoeken hoe je Workday het beste kan inrichten? Je bent creatief en zoekt graag de grenzen op van het systeem, maar wel op een manier die toekomstbestendig...
-
Support Comptabilité/compliance
il y a 1 semaine
Antwerpen, Flandre, Belgique SD Worx Staffing Solutions Temps plein**Introductie****Une opportunité dans le secteur bancaire vous intéresse ? Alors cette offre est peut être faite pour vous **Sd Worx Professionnals est à la recherche pour un de ses clients, spécialiste des crédits hypothécaire et situé dans la région de liège, d'un.e **Support Comptabilité/Compliance**.En tant que Support Comptable, vous...
-
Senior Data Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique g2 Recruitment Solutions Temps pleinSenior Data Specialist - Remote (Belgium) - PermanentI am currently working with a client that are looking for a Senior Data Specialist to join the team in Antwerp.The client is big on providing the most accessible and curated data on every mass consumer retail product. They are highly motivated about the quality of their data and are passionate on making it...
-
Senior Data Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique G2 Recruitment Solutions Temps pleinSenior Data Specialist - Remote (Belgium) - Permanent I am currently working with a client that are looking for a Senior Data Specialist to join the team in Antwerp.The client is big on providing the most accessible and curated data on every mass consumer retail product.They are highly motivated about the quality of their data and are passionate on making it...
-
Compliance & Legal Operations Manager | Lotus Bakeries
il y a 1 semaine
Antwerpen, Flandre, Belgique Brussels Airport Company Temps pleinJob title: Compliance & Legal Operations Manager | Lotus Bakeries The opportunity to join an ambitious and driven team with a mix of talents. Working at Lotus Bakeries is working in an environment where passion, team spirit and open dialogue are the main drivers. And of course, on top of that, you can enjoy delicious branded snacks every day. Moreover,...
-
Senior Talent Acquisition Specialist
il y a 1 semaine
Antwerpen, Flandre, Belgique ENGIE Temps pleinWelkom bij ENGIE BELGIUM Elke dag werken wij energie-efficiënte oplossingen uit en bouwen zo aan een koolstof neutrale toekomst Ben jij een ervaren Talent Acquisition partner die de huidige arbeidsmarkt beschouwt als een opportuniteit om de diversiteit, gelijkheid en inclusie te versterken binnen ENGIE België? Weet jij als geen andere hoe je op een...
-
Customs Compliance Manager
il y a 1 semaine
Antwerpen, Flandre, Belgique BDP International Temps pleinJob Description:The Customs Compliance Manager leads and manages the customs processes and systems in both improvement projects of existing customers and onboarding of new customers. Mainly diving the efficiency and profitability of the processes and making sure there is a robust structure for future growth. This all will be done in close cooperation with...
