Associate Manager, QA Auditor
Offer summary
Qualifications:
Bachelor’s degree with 4+ years of relevant industry experience, In-depth knowledge of FDA and EU regulations and ICH guidance documents, Experience with FDA or other Regulatory Inspections, Excellent communication skills and strong leadership abilities..Key responsibilities:
- Schedules, prepares, and conducts GxP audits as per standard operating procedures
- Assembles and coordinates the activities of the audit team
- Reports findings to management with recommendations for resolution
- Represents QA on compliance projects and initiatives across functional areas.
Job description
The Associate Manager QA Auditor applies expertise in Good Pharmacovigilance Practice (GxP) and international regulations to the auditing process to independently address a variety of GVP compliance issues associated with drug development and post-marketing authorization. The individual should have in-depth knowledge of the FDA and EU regulations and ICH guidance documents along with any other regulations that may affect drug development and post-authorization safety monitoring. This individual is expected to have an in-depth level of knowledge and experience in conducting one or more audit types (e.g. process, vendor, license partner, etc).
In this role, a typical day might include the following:
Schedules, prepares, and conducts audits in support of GxP audits as directed and in accordance with Regeneron standard operating procedures and quality policies. Audits include internal audits and external audits conducted globally.
Assembles and coordinates the activities of the audit team.
Reports findings to management with recommendations for resolution and verifies appropriate corrective actions have been implemented and documented.
Represents QA on teams, compliance projects and initiatives both within and across functional areas of Global Development
Interprets policies, standards, and regulations, and evaluates potentially critical problems not covered by policies and standards.
Exercises judgment in ensuring that written procedures are followed in evaluating quality systems, processes, procedures, and protocols for compliance.
Appropriately escalates any compliance issues.
This role may be for you if have:
Bachelor’s degree with 4+ years of relevant industry experience
Excellent communication skills and ability to work with people in all levels of the organization and externally.
Experience with FDA or other Regulatory Inspections
Strong leadership with demonstrated ability to interface with senior leaders
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)
Required profile
Experience
Other Skills
- Quality Control
- Communication
- Leadership