Manager Product Quality Owner
il y a 4 jours
Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager Product Quality Owner. The position should be based on the following sites: Raritan, NJ, Beerse, Belgium, Latina, Italy, Leiden, The Netherlands, Cork, Ireland, Malvern, Springhouse, Chesterbrook, USA, Schaffhausen in Switzerland, Guaynabo, Puerto Rico.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Manager Product Quality Owner has end-to-end accountability for the quality strategy and quality aspects of commercial products for an assigned portfolio of products.
**Key Responsibilities**:
Compliance with the GMP, EHS and SOX requirements and guidelines, as applicable. Serves as the single point of Global Quality contact for an assigned group of marketed products with low to medium complexity. Responsible for ensuring end-to-end Quality for assigned products across DS site(s), DP site(s), packager(s) and QC testing and release. The Quality Owner (QO) knows the product history and understands the processes across the various manufacturing sites. The QO establishes and maintains site Quality contacts and drives communication with all Q&C stakeholders. Assures Quality milestones and Quality deliverables are achieved and approves content of spec changes to ensure spec changes are aligned end-to-end. Supports multisite/global/high level product CAPAs and change controls to ensure they are approved and closed appropriately.
Represents Global Quality on the Value Stream Teams (VST). Maintains the flow of communications between Global Quality and VST teams. Brings Quality issues to the VST and assists with prioritization of projects and with key product decisions. Supports the business continuity process including VST strategy and BCP projects. Reviews Proactive Product Quality Scans with the VST and supports appropriate mitigating actions. Prepares quality sections of Product Strategy and End-to-end Value Stream Mapping. Participates in the F2F VST meetings on PSR and VSM finalization and project prioritization. Aligns and interfaces the JSC Product Strategy with other existing strategies: J&J corporate strategies, commercial strategies, R&D strategies, regulatory strategies, etc.
Accountable for all stability related activities of commercialized products including change management study management. Liaises with Product data specialists or Product quality specialists to gather input on stability topics (e.g. draft stability protocols and reports). Collaborates with a Product Quality Specialist on regulatory questions related to stability and on preparation of regulatory PA inspections regarding stability topics.
Defines and oversees the necessary QA resources for global and local Q of his or her assigned products.
- Leads a comprehensive Quality Sub team that assures Quality throughout, DS, DP, Fill Finish & Device:
- Assures product quality over the life cycle, understands the performance, and risk profile, throughout shelf-life
- Ensures patients get the right quality products.
- Supports the sites, represents the sites on VS Team.
- Supports QA communication/issue resolution with External Manufacturers and Business Partners, as applicable.
- Ensures standard Global Quality processes (risk assessments, technology transfers) are used across sites and facilitates communication throughout Global Quality
- Manages preparation of the PPQS in advance of Review Board and Executive Management Review.
- Supports preparation of the criticality analysis per schedule.
- Ensures complaints are well managed, issues are understood, and trends in Global Medical Safety, GMS are understood and addressed as necessary. Participate in product safety management teams to present Product Quality Complaints trends and topics.
- Coordinates and/or owner of complaints trend signal investigations.
- Partners with Quality Integrator to complete Transfer of Ownership activities.
- API, RM, FP specifications change approvals.
- Presents project updates to QM for Global Quality alignment
- Escalate issues when appropriate. Works with the cross functional/site teams to coordinate and hold Escalation meetings, minutes archival, follow up on actions. Participates and actively engages on IMTs. Supports field/recalls as needed.
- Demonstrate basic knowledge of new product launch (new filing, launches, regulatory impact, basic of clinical trials management) and supply network planning and supplier management.
**Decision making and Problem Solving**:
- Drives/coordinates decisions and makes decisions on behalf of Global Quality including sites.
- Gives inp
-
Senior Manager, Product Quality Management, Quality
il y a 7 jours
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior** **Manager, Product Quality Management, Quality Integrator**! The position can be based at one of the following sites: Wayne, PA; Titusville, NJ; Raritan, NJ; Horsham, PA; or Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen,...
-
Senior Manager, Product Quality Integrator
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA; or Chesterbrook,...
-
Senior Manager, Product Quality Management
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior** **Manager, Product Quality Management, Quality Integrator**! The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Raritan, NJ; Horsham, PA or...
-
Sr Manager Product Quality Integrator
il y a 3 jours
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior** **Manager, Product Quality Management, Quality Integrator**. The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA or Chesterbrook, PA At...
-
Manager Product Owner Udi
il y a 4 jours
Beerse, Belgique Johnson & Johnson Temps pleinJohnson & Johnson Service, Inc. is current recruiting for a Manager, Product Owner - Unique Device Identifier to be located on-site or near a Johnson & Johnson Services, Inc. site in the United States, Brazil, Belgium, or Ireland! Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We...
-
Lead Technical Product Owner
il y a 6 jours
Beerse, Belgique Johnson & Johnson Temps pleinJanssen R&D is recruiting for a Technical Product Owner to lead the Reference Ontology Governance (ROG) squad in Beerse, Belgium. At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our...
-
External Quality Manager
il y a 6 jours
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, External Quality (Small Molecules) located Europe or North America. In this position you will provide end to end quality oversight for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or...
-
Manager, R&d It, Bioresearch Quality
il y a 1 semaine
Beerse, Belgique Johnson & Johnson Family of Companies Temps pleinJanssen is recruiting for a Manager, R&D IT, BioResearch Quality & Compliance (BRQC) located in Raritan, NJ; or Beerse, BE. This position may require up to 20% travel (domestic and international). At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways...
-
Senior Digital Product Manager, Digital and Data
il y a 5 jours
Beerse, Belgique Johnson & Johnson Family of Companies Temps pleinIn this role, you will be responsible for defining and driving our digital product strategy and roadmaps. You will work with our Janssen Supply Chain business partners, in-house data scientists, data engineers, and product development teams to build and implement a cohesive roadmap. You will evangelize new features to our users, working to accelerate their...
-
Qc Manager Biotech
il y a 5 jours
Beerse, Belgique Johnson & Johnson Temps pleinThe Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a Manager Quality Control Biotech for the CAR-T manufacturing processes in EMEA. The position will be based in Beerse Belgium. CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eradicating cancer cells, which work by harnessing the...
-
SAP Make/qm Product Functional Specialist
il y a 3 semaines
Beerse, Belgique Johnson & Johnson Temps plein**Job Function**: Technology Product & Platform Management **Job Sub Function**: Functional Engineering **Job Category**: Scientific/Technology **All Job Posting Locations**: Beerse, Antwerp, Belgium, Ringaskiddy, Cork, Ireland Johnson & Johnson is recruiting for a **SAP Make/QM Product Functional Specialist** at the IT Lead level to support North America...
-
Head Oncology Quality Planning and Strategy
il y a 6 jours
Beerse, Belgique Johnson & Johnson Temps plein**Johnson & Johnson - Janssen, the pharmaceutical division of Johnson & Johnson, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neurosciences & analgesia, dermatology, infectious diseases and metabolic diseases in India. Driven by a strong commitment to the health and...
-
SAP Make/QM Product Functional Specialist
il y a 9 heures
Beerse, Flandre, Belgique Johnson and Johnson Temps pleinAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Manager 2 Pharma Quality Systems Capa
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Supply Group L.L.C. is recruiting for a Sr. Manager, Quality Systems CAPA, This position has a primary location of Titusville, NJ. It can also be based in Bern, Switzerland; Schaffhausen, Switzerland; Beerse, Belgium; Latina, Italy; Cork Ireland; Leiden Netherlands; Raritan, NJ or Gurabo, Puerto Rico. Outside of the United States, other consideration...
-
SAP Make/QM Product Functional Specialist
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
-
Clinical Compliance Business Operations Manager
il y a 9 heures
Beerse, Flandre, Belgique Johnson and Johnson Temps pleinAt Johnson & Johnson, we believe health is everything.Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to...
-
Sr Anlst Quality Assurance
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...
-
Quality Manager Car-t
il y a 1 semaine
Beerse, Belgique Brunel Temps plein**Brunel is an international company with a long and successful history in project sourcing. We owe our unique reputation to our strength and stability, but above all to our consultants. They make the difference. Their motivation, passion and energy form the basis of our success formula.** **Would you also like to be part of our team?** *** **For our...
-
Quality Engineer
il y a 3 semaines
Beerse, Flandre, Belgique Arcadis Temps pleinResponsible for integrating quality standards to mitigate failure mode risks during risk-based assessments in asset management design reviews.Ensure compliance of qualification activities.Review and approve qualification documents.Review and approve calibration and maintenance records.Review and approve certification master data.Responsible for reviewing and...
-
Product Analyst
il y a 5 jours
Beerse, Belgique Johnson & Johnson Temps pleinJohnson & Johnson Corporate Business Technology (CBT) is seeking for a **Product Analyst Payment **to support the AP Transformation program, which is part of the overall Transact initiative. The PA (Product Analyst) Payment is part of the Payment Squad team in the overall Transact Invoice to Pay stream and will lead the effort to design solutions that meets...
