![Regeneron Pharmaceuticals](https://media.trabajo.org/img/noimg.jpg)
Global Development Quality Governance and Oversight
2 months ago
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, hypercholesterolemia, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, allergic asthma, oncology, and atopic dermatitis.
Job duties, as per assigned GDQGO team, may include but are not limited to:
- Support the management of SSN cases (investigations, root cause analysis, and CAPA management) including closure of CAPA action items, as assigned.
- Support the SSN process by reviewing and collating data captured in Veeva electronic Quality Management System (eQMS).
- Assistance with the analysis of SSN and CAPA data in conjunction with GCP and GVP QMLs.
- Data mining from eQMS to support the analysis and trending of quality issues and events (SSNs/minor SSNs) at a vendor, program, and study level.
- Supports QML directors in the Serious Breach Process by arranging calls, taking minutes, and preparing required documentation
- Provides support to GCP QMLs engaged in activities such as reporting at study level Quality Risk management meetings QRMs and development and maintenance of the Quality Risk Assessment and Control Tracker (QRACT)
- Provide first line support to the eQMS system - QMOD.
- Monitor and track system enhancements.
- Assist in the system enhancements process through requirements gathering, overseeing technical development, testing and deployment.
- Author test script documents and support delivery of configuration change controls.
- Function as a super-user/QMOD expert on all system-supported processes and data requirements.
- Assistance with management of Inspection Readiness/Management and/or Quality Partnership Oversight forums including scheduling; agenda preparation; preparation of presentation materials; meeting minutes; maintenance of action logs and centralized filing of documentation.
- Liaise with key stakeholders within the business to support gathering of data and information relative to Inspection Management and/or Quality Partnership Oversight.
- Responsible for organization, management and maintenance of centralized Inspection Management documentation and Inspection Management related follow-up activities.
- Support preparation of materials for governance meetings.
- Responsible for organization, management, and maintenance of centralized Quality Partnership documentation.
- Management of Quality Partnership Process Deviations information and actions related to vendor deviations from Regeneron and/or vendor SOPs, as assigned.
- Support Quality Partnership audit related follow-up activities.
- Support collection, collation, and reporting of Key Quality Indicators (KQIs) with Quality Partnerships.
- Support process improvement initiatives and work groups, as assigned.
- May be required to support regulatory inspection activities.
- Disseminates essential information, status updates, and metrics to management on assigned projects.
- Collaborate with GD Quality colleagues, GD Systems, and other key stakeholders.
- Other duties as required or assigned.
Requirements:
- Must be enrolled in a full-time program (Bachelor's, Master's, or PhD) in a Life Sciences (or related) subject
- Must be enrolled in university full-time, following their work at Regeneron Pharmaceuticals Inc.
- Must be confident in ability to work as part of a global team, with several key stakeholders based in US, UK, and Ireland.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
-
Global Development Quality Governance and Oversight
2 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals Full timeKnown for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron markets medicines for eye diseases, colorectal cancer, hypercholesterolemia, and a rare inflammatory...
-
Global Quality Healthcare Specialist
1 week ago
Uxbridge, United Kingdom Kuehne + Nagel Full timeJoin Our Team as a Global Quality Healthcare Specialist Drive excellence in healthcare compliance! Be a key player in shaping industry-leading GxP quality standards that set our services apart and ensure our customers thrive in a competitive marketplace. As a Global Quality Healthcare Specialist, you will be instrumental in developing and implementing...
-
Global Quality Healthcare Specialist
2 weeks ago
Uxbridge, United Kingdom Kuehne Nagel Full timeJoin our team as a Global Quality Healthcare Specialist and drive excellence in healthcare compliance! Be a key player in shaping industry-leading GxP quality standards that set our services apart and ensure our customers thrive in a competitive marketplace. Your Role As a Global Quality Healthcare Specialist, you will be instrumental in developing and...
-
Director, Global Provider Networks
10 hours ago
Uxbridge, United Kingdom Cover-More Full timeAbout the RoleThe Director of Global Provider Networks is a critical position within our organization, responsible for developing and implementing a functional network provider strategy that drives global network quality, operational performance, and financial outcomes.Key ResponsibilitiesLead the creation of a Global Network Operating Model, establishing...
-
Assoc Dir Gps Quality
3 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals Inc. Full time**Summary**: This position is responsible for supporting the quality & compliance activities associated with Global Patient Safety (GPS). Such activities include developing, performing, trending and analyzing quality and compliance metrics and associated outputs related to Safety Sciences Quality & Compliance deliverables. This role will be reporting into...
-
Director of Global Health Networks
12 hours ago
Uxbridge, United Kingdom Cover-More Full timeJob DescriptionJob SummaryAt Cover-More, we are seeking a highly skilled and experienced professional to lead our global health network strategy. As the Director of Global Health Networks, you will be responsible for developing and implementing a comprehensive network strategy that ensures the delivery of high-quality healthcare services to our customers.Key...
-
Director: Global Development Systems Regional Lead
2 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals Full timeThe Global Development Solutions (GDS) Regional Systems Lead, who is responsible for leading Global Development technology projects by partnering with key business stakeholders to intake, design implement and enhance including production support. This role will work closely with other Global Business Solution Partners (BSP), Implementation Leads and System...
-
Director: Global Development Systems Regional Lead
2 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals Full timeThe Global Development Solutions (GDS) Regional Systems Lead, who is responsible for leading Global Development technology projects by partnering with key business stakeholders to intake, design implement and enhance including production support. This role will work closely with other Global Business Solution Partners (BSP), Implementation Leads and System...
-
Global Health Provider Strategy Lead
8 hours ago
Uxbridge, United Kingdom Cover-More Full timeJob DescriptionJob SummaryCover-More is seeking a highly experienced and skilled professional to lead our global healthcare provider network strategy. As the Director of Global Health Networks, you will be responsible for developing and implementing a comprehensive network strategy that ensures high-quality, cost-effective healthcare services for our...
-
Senior Manager, Compliance Oversight
7 hours ago
Uxbridge, United Kingdom Gilead Sciences Europe Ltd. Full timeAbout the RoleGilead Sciences Europe Ltd. is a leading biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. We are seeking a highly skilled Senior Manager of Compliance Oversight to join our team in London.Key ResponsibilitiesSupport the Global Compliance Monitoring Director in developing...
-
Global Quality Manager
3 weeks ago
Uxbridge, United Kingdom Cover-More Full timeJob Description At World Travel Protection (WTP), protecting people is our priority. We take care of corporate and leisure travellers, helping them avoid risks before they escalate and providing them with immediate access to the right experts when an emergency happens while travelling. Our extensive experience in global travel risk management...
-
Global Clinical Program Management Sr. Manager
3 weeks ago
Uxbridge, United Kingdom Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better...
-
Director Global Compensation
2 months ago
Uxbridge, United Kingdom Hasbro Full timeAbout The Team The Compensation team leads compensation programs for Hasbro. Our work impacts every employee globally through the programs we coordinate. The team also has a meaningful role to play by ensuring our employee value proposition is competitive in the marketplace and financially balanced. About the Role The Compensation Director will...
-
Uxbridge, United Kingdom Gilead Sciences International, Ltd. Full timeJob Summary:This is an exciting opportunity for an Associate Director, Regulatory Affairs to join the Gilead Global Regulatory Affiliates & Distributor team to provide oversight and management of regulatory activities provided by Gilead's in-market partners in the Gilead Patient Solutions (GPS) region (South Asia, South-East and Central Asia and Africa).Key...
-
Sr Mgr Global Development Systems
2 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals Full timeThe Global Development Solutions (GDS) Regional Systems Lead, who is responsible for leading Global Development technology projects by partnering with key business team members to intake, design implement and enhance including production support. This role will work closely with other Global Business Solution Partners (BSP), Implementation Leads and System...
-
Sr Mgr Global Development Systems
2 months ago
Uxbridge, United Kingdom Regeneron Pharmaceuticals Full timeThe Global Development Solutions (GDS) Regional Systems Lead, who is responsible for leading Global Development technology projects by partnering with key business team members to intake, design implement and enhance including production support. This role will work closely with other Global Business Solution Partners (BSP), Implementation Leads and System...
-
Director Global Compensation
3 weeks ago
Uxbridge, United Kingdom Hasbro Full timeAt Hasbro we’re changing the face of play and entertainment. We’re looking for people who want to explore, experiment and innovate to come up with the best ideas. Our culture of community, passion, integrity, creativity and inclusion has inspired our diverse team of highly skilled, highly creative and highly committed individuals for 90+ years and we...
-
Uxbridge, United Kingdom Gilead Sciences International, Ltd. Full timeJob SummaryGilead Sciences International, Ltd. is seeking a highly experienced and skilled Executive Director to lead the Global Regulatory Affairs and Labeling function. This role will be responsible for overseeing the development and implementation of global labeling strategies, ensuring compliance with regulatory requirements, and driving innovation in...
-
Director Global Compensation
2 months ago
Uxbridge, United Kingdom Hasbro Full timeAt Hasbro we’re changing the face of play and entertainment. We’re looking for people who want to explore, experiment and innovate to come up with the best ideas. Our culture of community, passion, integrity, creativity and inclusion has inspired our diverse team of highly skilled, highly creative and highly committed individuals for 90+ years and we...
-
Director Global Compensation
4 weeks ago
Uxbridge, United Kingdom Hasbro Full timeAt Hasbro we’re changing the face of play and entertainment. We’re looking for people who want to explore, experiment and innovate to come up with the best ideas. Our culture of community, passion, integrity, creativity and inclusion has inspired our diverse team of highly skilled, highly creative and highly committed individuals for 90+ years and we...