Associate Manager, GD Quality Operations
3 months ago
JOB DUTIES:
Supporting External Partnership Quality Oversight Activities, including:
Quality Oversight Meetings (preparation, QE trending, KQIs, materials, minutes, tracking of actions);
Revision and tracking of Quality Agreements, including training materials;
GDQOP Mailbox management (external process deviations, incoming KQIs, queries from vendors);
Triage and Data entry of External Reported Process Deviation into the eQMS;
External Partnership Customer Feedback Process (survey management, analysis and reporting);
Maintenance of vendor oversight documentation in EPOD, including compliance checks;
Revisions to GDQOP procedural documents, associated forms and templates, including training materials.
Support GDQOP operational activities, including maintenance of Academy Pages; metrics & analytics; procedural document management; inspection notifications.
Supporting GDQGO planning & operational activities, including infrastructure (JDs, staffing info, org charts, career roadmaps); staff onboarding; organization and coordinate of team meetings/events; training curricula management; tracking of T&E budget/spend, maintenance of GDQGO Academy Page); integration support.
General support to GDQGO team, as assigned.
JOB REQUIREMENTS:
Bachelor’s degree with a minimum of 5 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).
Experience in training, supervising and/or mentoring staff.
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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