Auditing Director jobs in New York

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 internal and 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:

• 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 for each level:

Level to be determined based on qualifications relevant to the role.

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