We are currently looking to fill an Associate Director of Quality Auditing position. This position will be responsible for providing professional expertise, leadership, oversight and planning for the Regeneron Quality Auditing function, with primary emphasis on GMP, IT and Quality audits that may impact GMP operations and/or product. Quality (GMP) Auditing is responsible for maintaining the external audit programs and performing audits for Regeneron.
The work location is onsite at Regeneron's Rensselaer, NY facility - not a remote based opportunity.
In this role, a typical day might include the following:
Maintaining professional expertise and knowledge of audit criteria including, but not limited to, internal company policies and procedures, and applicable local and international regulations, standards and guidelines (e.g., Chapter 21 of the Code of Federal Regulations, Eudralex Volume 4 and associated Annexes, ISO Standards, and ICH, WHO and IPEC Guidelines, etc.)
Supervising and presenting industry trends as they relate to regulatory agency findings, expectations and warning letters
Collaborating with Procurement, External Manufacturing, Drug Product Quality, QA & Operations and other team members and audit clients pertaining to supplier audits
Leading all aspects of the audit programs and audit schedules for GMP/Quality and IT audits
Strategically planning, prioritizing and handling resources to meet audit schedules, company and departmental goals and objectives, and quality standards
Providing direction on auditing matters, and providing leadership, mentorship and supervision to auditing personnel; promote a GxP and Quality approach
Planning, leading, performing and/or supervising audits
Handling the selection, training, onboarding and biennial assessment of proxy auditors
Coaching, developing and mentoring employees to drive succession planning and business continuity planning
Compiling, organizing, and communicating auditing Right to Operate (RTO) metrics to senior management
Ensuring the training and qualification program for GMP Auditing employees is appropriate and adequately maintained
Reassessing auditing processes and procedures periodically for continuous improvement opportunities to ensure optimal performance; continually improve in a strategic and thoughtful manner
This role may be for you if you:
Have 10 years of proven experience leading a GMP auditing team
Can ensure auditing processes and procedures meet the minimum regulatory requirements and ensure current industry standards and expectations and are followed
Enjoy being accountable for the performance and results of the Quality (GMP) Auditing Department
Enjoy travel, domestic and international, up to 15% of your time
To be considered for this role you must hold a Bachelor’s degree in a life sciences subject area or related field (chemistry, biology, or pharmacy preferred) and 10+ years of pharmaceutical/biotechnology industry experience, including experience with Quality Systems and auditing.
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)
Similar Jobs
.png)
What We Do
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.
