Regeneron
Senior Manager, Global Development Quality Standards & Continuous Improvement
About the job
The Manager, Global Development Quality Standards & Continuous Improvement (GDQSCI) will support the GDQSCI team with activities related to the maintenance of the Global Development Quality Management System (QMS), quality event oversight and improving processes for quality standards, governance, and oversight, as assigned.
This is a hybrid position with 3 days on-site requirement.
In this role, a typical day might include the following:
- Supporting the engagement of key stakeholders across Global Development functions to proactively identify process improvements, standardizations and regulatory compliance that impacts the Regeneron Global Development quality system.
- Responsible for managing the reporting and provision of quality-related metrics and trends to enable functions to continuous improvement.
- Responsible for managing the Quality Event (QE) portfolio and the provision of Subject Matter Expert (SME) expertise and guidance to relevant functional areas
- Responsible for governance and oversight activities, including facilitation of oversight meetings and preparation and presentation of data supporting the health of the QMS.
- Responsible for championing of the Quality Management System, including increasing awareness of the QMS within Global Development to influence quality culture.
This Role May Be For You If Have
- Knowledge, understanding and application of GCP, and/or GVP guidelines including the management of fundamental quality issues and compliance activities.
- Knowledge and understanding of quality management system (QMS) oversight, governance of quality processes, quality event oversight and continuous improvement.
- Effective management of interpersonal relationships and collaborations.
- Experience serving as a subject matter expert/process owner/business process owner in a quality related field/area.
- Experience in providing training and presenting information on key quality and regulatory compliance information.
To be considered for this opportunity we are looking for:
- 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).
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, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
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.
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