The Senior Manager, Global Development Quality Management (GCP) acting as a Quality Management Lead (QML) is a key position that will provide guidance and leadership for all aspects of quality and compliance within Global Development Quality (GDQ) systems. The GDQM (GCP) QML will engage with key stakeholders, build strategic partnerships working and liaising with study teams, relevant functions and other GDQ functions to lead risk-based quality management activities on all Regeneron-sponsored clinical trials, inclusive of issue management and providing continuous support of inspection readiness.
For US locations (Armonk, NY or Warren, NJ), this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position.
A day in the life may look like:
• Acting as a Subject Matter Expert (SME) and key liaison to GDQ to provide support and advise on any quality issues to ensure compliance and for the Quality Risk Assessment process.
• Ensuring and responsible for Risk-Based Quality Management (RBQM) initiatives and process improvements, in partnership with other functional areas.
• Responsible for the management of GCP-compliant activities from a quality perspective in conjunction with the business and the GDQM (GCP) team.
• Providing day-to-day quality and compliance support to cross-functional stakeholders, including issue management (triage/investigation/actions), audit responses, proactive quality management, Corrective Action/Preventive Action (CAPA) oversight, audit/issue trending.
• Engaging with, supporting, and liaising with multiple cross-functional stakeholders whose work impacts the GDQ system.
• Leading Quality Risk Assessment and Control Tracker (QRACT) activities at the time of Protocol development predicated on ICHGCP.
This may be the right role for you if you have experience:
• Bachelor's degree with a minimum of 8 years of relevant healthcare/pharmaceutical industry experience.
• Experience working in either a quality/compliance role (e.g., Quality Management, Quality Assurance etc.), or in a Clinical Development role with expertise and/or transferable skills related to Good Clinical Practice (GCP), and/or Good Pharmacovigilance Practice (GVP).
• Providing consultation, mentorship, training, and support in respect to compliance with applicable international regulations, practices, and guidelines.
• Advising on the escalation of any quality issues that potentially represent serious non-compliances (or serious breach) via the issue escalation process.
• Supporting the collection and reporting of data (e.g., metrics).
• Contributing to and supporting process improvement initiatives and workgroups, as assigned.
• Exemplifying a quality mindset and behaviors in all interactions with internal and external colleagues, serving as an ambassador for GDQ.
In order to be considered for this role, we are looking for candidates who have:
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in. Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media. An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
