BioSpace, Inc.
Senior Manager, Global Development Quality Management (GVP)
BioSpace, Inc., Basking Ridge, New Jersey, us, 07920
Job Details
The Regeneron GVP Quality Management Lead (QML) is a key position that we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality management activities with key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at all times. The GVP QML will partner with other members of the Global Development Quality Governance and Oversight (GDQGO) department to identify trends through metrics in order to diagnose and remediate systemic quality issues. In this role, a typical day might include the following:
Responsible for leading GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director, GVP QML Engage with, support and liaise with multiple cross-functional collaborators whose work impacts the Regeneron global PV system, including but not limited to: Global Patient Safety (GPS), Medical Affairs, Regulatory, Commercial, etc. Participate in process improvement activities, lead projects in support of quality objectives, and support inspection readiness activities Act as a primary liaison to GPS to advise on any quality issues and ensure compliance Provide day-to-day quality and compliance support to cross-functional team members, including Suspected Serious Non-compliance (SSN)/issue management (triage/investigation/actions), audit responses, proactive quality management, CAPA oversight, audit/issue trending This role may be for you if:
You have skills in taking initiative and working independently across multiple areas. You can make decisions on complex issues under minimal guidance that have a significant impact on business operations related to PV. You are self-motivated with the ability to work effectively and provide mentorship to others in a dynamic environment with ambiguity. You bring expertise of GVP and are a sought-out resource to evaluate novel problems and develop innovative solutions for critical organization-wide issues. You have acted as a PV expert, managed quality and compliance issues related to post-marketing and clinical trial safety
To be considered,
we are looking for individuals with a Bachelors degree (Masters degree preferred) or equivalent qualification with 8+ years of relevant industry experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.
Salary Range (annually) $129,800.00 - $211,800.00
The Regeneron GVP Quality Management Lead (QML) is a key position that we believe will guide and lead all aspects of quality and compliance within global pharmacovigilance (PV) system. We expect the Sr. Manager to build strategic partnerships and direct risk-based quality management activities with key partners impacting the global Regeneron PV system. Furthermore, the GVP QML Sr. Manager will be responsible for supporting inspection readiness at all times. The GVP QML will partner with other members of the Global Development Quality Governance and Oversight (GDQGO) department to identify trends through metrics in order to diagnose and remediate systemic quality issues. In this role, a typical day might include the following:
Responsible for leading GVP-compliant activities from a quality perspective in conjunction with business and Associate Director / Director, GVP QML Engage with, support and liaise with multiple cross-functional collaborators whose work impacts the Regeneron global PV system, including but not limited to: Global Patient Safety (GPS), Medical Affairs, Regulatory, Commercial, etc. Participate in process improvement activities, lead projects in support of quality objectives, and support inspection readiness activities Act as a primary liaison to GPS to advise on any quality issues and ensure compliance Provide day-to-day quality and compliance support to cross-functional team members, including Suspected Serious Non-compliance (SSN)/issue management (triage/investigation/actions), audit responses, proactive quality management, CAPA oversight, audit/issue trending This role may be for you if:
You have skills in taking initiative and working independently across multiple areas. You can make decisions on complex issues under minimal guidance that have a significant impact on business operations related to PV. You are self-motivated with the ability to work effectively and provide mentorship to others in a dynamic environment with ambiguity. You bring expertise of GVP and are a sought-out resource to evaluate novel problems and develop innovative solutions for critical organization-wide issues. You have acted as a PV expert, managed quality and compliance issues related to post-marketing and clinical trial safety
To be considered,
we are looking for individuals with a Bachelors degree (Masters degree preferred) or equivalent qualification with 8+ years of relevant industry experience.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. 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.
Salary Range (annually) $129,800.00 - $211,800.00