Global Development Quality Governance and Oversight

2 months ago

Uxbridge, United Kingdom Regeneron Pharmaceuticals Full time

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.

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