Compliance Manager
Il y a 6 mois
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”
**Major Responsibilities**:
- Lead and complete internal audits (schedule, issue agenda, prepare, conduct audit, issue report)
- Organize and complete compliance walk-throughs (e.g. GEMBA)
- Evaluate responses to internal audits
- Enter internal audit data into quality system
Support external GMP audits and inspections (Health Authority, Customer). Including:
- Inspection Readiness (audit preparation, schedule and manage mock inspections, SME coaching).
- Partner with Quality to manage inspections (host and/or coordinate front room and back room, issue daily inspection summaries).
- Prepare/review site responses and associated CAPA for Health Authority/Customer inspections.
- Identify changes in regulations that impact compliance procedure, perform comparisons against current practices.
Provide Compliance Subject Matter Expertise (SME) for site personnel, Quality Systems and/or projects. As needed, review complaints and field actions.
May represent Regulatory Compliance at Site Management Reviews, CAPA Review Boards, Escalations, Platform Compliance meetings, etc.
Partner with site for execution of proactive compliance scans.
Partner with site and segment personnel (e.g. Regulatory Affairs, Operations, Product Quality Management, etc) to proactively identify risks and drive compliance improvement across the site.
**Other Duties**:
- Connect with external groups (e.g. PDA, ISPE, etc.) to benchmark industry standards.
- As needed, co-authors, review, and revise compliance procedures.
- As needed, review (not approve) significant manufacturing and laboratory investigations, confirmed complaints and S1/S2 Field Actions.
- Conduct Mock Recalls.
**Qualifications**:
**Required Qualifications**:
- Bachelor’s degree in science or related field
- At least 7 years of related experience in a GMP-regulated industry, inclusive of regulatory compliance experience.
- Knowledge of global GMP and ATMP regulations is required.
- Preferred experience and knowledge of/with Advanced Therapies and/or CAR-T.
- Strong analytical skills. Ability to clearly articulate issues.
- Must have excellent communication skills, able to quickly build credibility within the Quality and Compliance communities.
- Delivers on commitment timelines and has high sense of urgency.
- Experience performing internal or external audits of GMP regulated facilities.
**Travel Requirements**:
- Domestic travel is possible
- Approximately 10-15% travel.
**Preferred Qualifications**:
- QA/RA certification is preferred.
- 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._
-
License Compliance Manager
Il y a 6 mois
Gent, Belgique Apryse Temps plein**Company Overview**: We are excited to announce an opportunity for a talented License Compliance Manager to join our dynamic team. If you're passionate about ensuring software license compliance, we want to hear from you. Join us in shaping the future of our organization as we navigate the exciting world of licensing compliance. Your main duties as a...
-
Legal & Compliance Manager
Il y a 6 mois
Gent, Belgique WILLEMOT Temps plein**Willemot, opgericht in 1841, is een gedreven familiale onderneming en dochter van de Duitse beursgenoteerde financiële holding OVB. Als master broker faciliteren en ondersteunen we de werking van onze lokale verzekeringstussenpersonen en vormen we de schakel tussen de eindklant en de verzekeringsmaatschappijen op de Belgische en Luxemburgse markt. Op de...
-
Business Manager Data Compliance
Il y a 5 mois
Gent, Belgique CRANIUM Temps plein**Do you speak the language of data governance and compliance, and are you ready to switch gears from managing data to managing relationships as well?** Then we might have the perfect opportunity for you. CRANIUM is the reference for privacy, security, and data management solutions within the Benelux. As our Business Manager for the Ghent region, you play...
-
Senior Accountant
il y a 1 mois
Gent, Belgique Deliverect Temps plein**Deliverect** As a rapidly scaling global SaaS unicorn, Deliverect stands at the forefront of revolutionising technological solutions for the dynamic hospitality and Q-commerce sectors. Our mission is clear: to empower ambitious individuals with the skills and knowledge to make a positive impact on business. Developing in their professional careers, all...
-
Legal Counsel: corporate
il y a 4 jours
Gent, Belgique Jacon Legal Consulting BVBA Temps pleinOnze klant Lotus Bakeries is wereldwijd actief in het segment van traditionele en natuurlijke tussendoortjes met de merken Lotus, Lotus Biscoff, Lotus Dinosaurus, Lotus Suzy, Peijnenburg, Snelle Jelle, Annas, Nākd, Trek, BEAR en Urban Fruit. Lotus Bakeries, met hoofdzetel in België, is een dynamische en internationaal georiënteerde onderneming met...
-
QAra Manager Healthcare
Il y a 6 mois
Gent, Belgique Robovision Temps plein**Who are we?** **Robovision** is a rapidly growing company at the forefront of AI development in Europe and beyond. We are active in several verticals, and for our healthcare vertical we’re developing state-of-the-art AI algorithms that will improve the outcomes and standard of care in hospitals. For this activity, we are looking for an exceptional...
-
Global Payroll and Benefits Manager
Il y a 3 mois
Gent, Belgique Human8 Temps pleinThe Global Payroll and Benefits Manager is part of the People & Culture (P&C) Team reporting into the Global Rewards and HR Data Manager. The Global Payroll and Benefits Manager is responsible for overseeing and managing payroll and benefits across 17 countries and 3 regions (US, APAC, EMEA) and is leading a team of 5 payroll and benefits specialists. The...
-
Clinical Trial Manager
Il y a 7 mois
Gent, Belgique Meet Recruitment Temps pleinClinical Trial Manager - Belgium - Pharma - Leading global cross-functional project team delivery, accountable for achievement of milestones and quality of contracted scope - Developing study management plans and ensuring consistent use of study tools, training materials and compliance with standard processes, policies and procedures Anticipating risk and...
-
Domain Product Specialist
Il y a 6 mois
Gent, Belgique team.blue Global Temps plein**Our business** Meet team.blue - the force behind the digital transformations of over 2.5 million customers across Europe. Our mission? Empower them to thrive in the online world, from building and growing to scaling their digital presence. **Job Overview** **Key Responsibilities**: - **Project Management**: - Plan, execute, and oversee projects related...
-
Billing Manager
Il y a 7 mois
Gent, Belgique Cerba Research Nederland Temps plein**Your responsibilities include**: - Oversee clinical trial billing process, coordinating with other departments and ensuring timely invoicing and financial setup. - Generate and analyze monthly reports, including revenue and KPI metrics, for the head of billing. - Maintain documentation, train staff, and implement enhancements to billing systems. -...
-
Verantwoordelijke Product Management Sparen
Il y a 6 mois
Gent, Belgique VDK Bank Temps plein**De uitdaging**: - Je bent verantwoordelijk voor het productaanbod van spaar -en beleggingsproducten, waaronder spaarrekeningen, termijnrekeningen, kasbons, beleggingsfondsen, structured notes, spaar -en beleggingsverzekeringen, pensioensparen en langetermijnsparen. - Je stippelt de korte en lange termijn visie voor het productaanbod uit. - Je vertaalt de...
-
Quality Manager
Il y a 6 mois
Gent, Belgique Element Materials Technology Temps pleinOverview: We are looking for an experienced **Quality Manager** to join our team and take responsibility for ensuring that our services meet the highest quality standards. You will have a strong background in quality management and a proven track record of implementing and maintaining quality management systems. This includes the quality management system...
-
Office Manager
Il y a 3 mois
Gent, Belgique Integra LifeSciences Temps pleinChanging lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes. The Office Manager Benelux...
-
QA Lab and Data Integrity Management Car-t
Il y a 6 mois
Gent, Belgique Johnson & Johnson Temps pleinThe Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab and Data Integrity associate for the CAR-T hub in Europe. The position will be based in Gent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own...
-
Product Manager
Il y a 2 mois
Gent, Belgique Vendorvue Temps pleinAs a Product Manager at Vendorvue, you’ll play a crucial role in transforming the compliance landscape for procurement teams. You’ll work closely with clients to understand their needs and translate those insights into actionable product requirements, all while keeping a visionary eye to surprise our clients with innovative ideas. Expect to tackle...
-
Product Portfolio Manager
Il y a 5 mois
Gent, Belgique team.blue Global Temps plein**Our Business** **team.blue is an ecosystem of successful brands working together across regions to provide customers with everything they need to succeed online. 40+ successful brands make up the group; within those brands, over 2000 experts serve its 2.5+ million customers across Europe and beyond.** **Product Portfolio...
-
Warehouse Project Manager
Il y a 6 mois
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview** The Warehouse Project...
-
Manager Purchase
Il y a 3 mois
Gent, Belgique Bio Base Europe Pilot Plant Temps pleinin Gent ;**Bio Base Europe Pilot Plant** was founded in 2008 and currently employs more than 160 staff members. It is a unique and open innovation pilot and demonstration facility for process development, scale-up and custom manufacturing of biobased products and processes from lab to multi ton scale. A wide and flexible spectrum of modular unit operations...
-
Technical Support Manager
Il y a 5 mois
Gent, Belgique Legend Biotech EU Temps plein**Company Information** Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma. **Role Overview** The Technical Support...
-
QA Project Manager, Car-t Emea
Il y a 2 mois
Gent, Belgique Johnson & Johnson Temps pleinJohnson & Johnson (J&J) is recruiting a QA Project Manager for the CAR-T hub in Europe. The position will be based in Ghent Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. They are created from the patients’ own T cells and...