Associate Director, GMP Auditing

Rensselaer, NY, United States
Nov 11, 2020
Required Education
Bachelors Degree
Position Type
Full time

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 IOPS 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 internal and external audit programs and performing audits for Regeneron. This position will ensure auditors have the education, experience and/or training vital to be able to identify compliance issues and find resolution in a highly autonomous manner.

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 stakeholders and audit clients pertaining to supplier audits
• Leading all aspects of the internal and external 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

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

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 pharmaceutical/biotechnology industry experience, including experience with Quality Systems and auditing. 10 years of managerial experience is required. Level to be determined based on qualifications relevant to the role

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.