Senior Local Compliance Specialist
Il y a 7 mois
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 go-to 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.
- Co-host 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 4-6 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 win-win 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 6 mois
Antwerpen, Belgique Manuchar Temps pleinThe Job You 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...
-
Acheteur Local Senior
Il y a 7 mois
Antwerpen, 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...
-
Local Medical Safety Process Head
Il y a 6 mois
Antwerpen, 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...
-
Head of Compliance
Il y a 7 mois
Antwerpen, Belgique Robert Half Belgium Temps plein**Robert Half** **Talent Solutions** is currently looking for a **Head of Compliance **for a permanent position based in Antwerp. **Robert Half** **Talent Solutions** is currently looking for a **Head of Compliance **for a permanent position based in Antwerp. Our client is a fast growing company active in the **banking sector**. As **Head of Compliance...
-
Senior Compliance Engineering
Il y a 6 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinJohnson & Johnson Innovative Medicine is the most innovating pharmaceutical company in the world. Since 2009 13 new medicines have been launched of which several ground-breaking in their therapeutic area. Within our department “Engineering & Property Services” we would also like to take this role as innovator. This by handling the infrastructure in a...
-
Head of Compliance, Belgium
il y a 4 semaines
Antwerpen, Belgique Binckbank Temps pleinHead of Compliance, Belgium Are you an experienced compliance professional with at least 5 years' experience? Do you have a diverse skillset with a desire to both set the direction and execute it? Within the Compliance team of the Saxo Bank Mid-Europe Region, we are looking for a Head of Compliance & Risk Management for our Belgium Branch (Antwerp). You do...
-
Senior Financial Controller
Il y a 6 mois
Antwerpen, Belgique Katoen Natie Temps plein**Job 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...
-
Head of Compliance, Belgium
Il y a 4 mois
Antwerpen, Belgique Saxo Bank Temps pleinHead of Compliance, Belgium Are you either an experience compliance professional with at least 5 years'+ experience? Do you have a diverse skillset with a desire to both set the direction and to execute it? Within the Compliance team of the Saxo Bank Mid-Europe Region we are looking for a Head of Compliance & Risk Management for our Belgium Branch...
-
Manager Manufacturing
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinThis position reports to the Head, Technology Compliance. **Approximate Percentage of Time**: **Tasks/Duties/Responsibilities** 60% **Risk-Based Closed Loop Supplier Audit and Periodic Review Programs**: - Leads and executes closed loop periodic reviews of J&J Segment (Pharm, Med Tech and Enterprise) GxP computerized systems that are supported by...
-
Specialist Customs Compliance
il y a 4 semaines
Antwerpen, Belgique H.Essers Temps pleinBen jij klaar om jouw passie voor customs en logistiek te combineren in de dynamische rol van Specialist Customs Compliance? Ontdek hieronder de uitdagingen en beloningen die gepaard gaan met deze rol bij H.Essers. **JOUW UITDAGINGEN** Als Specialist Customs Compliance coördineer je het internationale vervoer over de grenzen heen, zodat het transport...
-
Senior Quality Assurance Specialist
Il y a 7 mois
Antwerpen, Belgique Oxford Global Resources Temps plein**Senior Quality Assurance Specialist - System Qualification**: - Location: Antwerp, Belgium - Contact: Dardo Helpers - Job type: Contract - Contact phone: +32 15 445 852 - Industry: Pharmaceutical Als ervaren persoon binnen QA ben jij actief als specialist in de farmaceutische QA systemen. Je komt in een gestructureerd intarnationaal team terecht binnen...
-
Senior Cards Systems Specialist
Il y a 3 mois
Antwerpen, Belgique Q8 Temps pleinSenior Cards Systems Specialist - Ben jij een IT-professional met technische expertise en een flinke dosis ambitie? - Krijg je energie van uitdagende projecten en veelzijdige verantwoordelijkheden binnen kaart - en betaalplatforms? - Wil je meewerken aan een excellerende digitale klantbeleving? - Ben jij een sterke communicator en teamspeler die graag impact...
-
Cybersecurity and Compliance Officer
Il y a 2 mois
Antwerpen, Belgique Tech & IT People™ Temps pleinAre you a **Cybersecurity and Compliance Officer** passionate about leading enterprise-wide risk management initiatives? Join us, and let's work with our **cross-national team** on projects that protect critical infrastructure through advanced threat detection. You'll be able to work with advanced compliance frameworks and international security...
-
Senior Legal and Compliance Counsel
il y a 4 semaines
Antwerpen, Belgique Page Executive Temps plein- Exciting, challenging career opportunity in a highly international environment - Global technology leader, offering innovative products across various industries About Our Client Our client is a global technology leader, offering innovative products across imaging, healthcare, printing, and semiconductor industries. Its European operations include...
-
Senior Legal and Compliance Counsel
il y a 4 semaines
Antwerpen, Belgique Page Executive Temps pleinAbout Our Client Our client is a global technology leader, offering innovative products across imaging, healthcare, printing, and semiconductor industries. Its European operations include multiple subsidiaries and business units which oversee manufacturing, R&D, sales, and services. With over 70 group companies and 7,000 employees in EMEA, our client's...
-
Senior Scientist, Animal Welfare
Il y a 7 mois
Antwerpen, Belgique Johnson & Johnson Temps pleinThe Janssen Campus in Belgium is a major innovation hub and is part of the pharmaceutical companies of Johnson & Johnson. It brings together a unique mix of expertise, skills, and partnerships in research and development (R&D), manufacturing, and the launch of new drugs. We are working together to create a future where disease is a thing of the...
-
Saxo Bank | Head of Compliance and Risk Management, Belgium
il y a 4 semaines
Antwerpen, Belgique BestForexBonus.com Temps pleinSaxo Bank | Head of Compliance and Risk Management, Belgium Job description: 1. Determine the direction of Compliance and Risk Management Belgium and manage the team. 2. Give the first line solicited and unsolicited advice on all possible compliance topics. 3. Assess and report potentially suspicious customer transactions and advise on high-risk customer...
-
Senior QA Specialist
Il y a 4 mois
Antwerpen, Belgique NonStop Consulting Temps plein**Senior QA Specialist - Pharma/Device combination** Working directly with this client on their payroll, this a dynamic organisation with a strong presence in Belgium and beyond and they are offering a unique opportunity for a Senior QA Specialist to join their team located in Antwerp, Belgium. With 2 out of 3 manufacturing sites based in Belgium, fluency...
-
IG Markets | Head of Compliance and Risk Management, Belgium
il y a 4 semaines
Antwerpen, Belgique BestForexBonus.com Temps pleinIG Markets | Head of Compliance and Risk Management, Belgium Job description: Determine the direction of Compliance and Risk Management Belgium and manage the team. Act as the AML Compliance Officer towards the NBB. Give the first line solicited and unsolicited advice on all possible compliance topics. Assess and report potentially suspicious customer...
-
Power Technique Business Area Trade Compliance
Il y a 3 mois
Antwerpen, Belgique Atlas Copco Airpower N.V. Temps plein**Power Technique Business Area Trade Compliance Manager**: - Functional area: Administration- Country: Belgium- City: Antwerp- Company name: Atlas Copco Airpower N.V.- Date of posting: Sep 24, 2024 Our solutions are a key part of most industries - electronics, medical research, renewable energy, food production, infrastructure and many more. Working with...
