SENIOR MANAGER GD AUDITING – Regeneron

Job Description

JOB DESCRIPTION

The Senior Manager, QA-CSV (Quality Assurance – Computer System Validation) Auditing is a key position in the Global Development Quality Assurance (GDQA) group and will provide mentorship and leadership for the CSV Auditing group. We will task you to build strategic partnerships and implement risk-based quality auditing activities across GDQA. We feel the CSV Auditor should apply their expertise in GxP, CSV and international regulations to the auditing process to independently address a variety of CSV compliance issues. We expect the Auditor to 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. We expect you to lead audits of higher complexity (e.g., directed audits) and is expected to have a deeper level of knowledge and experience in conducting all audit types (e.g., process, site, vendor, license partner, etc.), depending on the GxP requirements.

We assume the Auditor would be considered a top subject matter expert who possesses an advanced knowledge of the Global Development Organization. One of the key objectives for the Senior Manager, Auditing, is to support the development and execution of departmental goals and objectives and to assist with the training and mentoring of audit staff.

In this role, a typical day might include the following:
• Scheduling, preparing, conducting, reporting and follow-up on routine and directed CSV audits in accordance with Regeneron standard operating procedures and quality policies.
• Audits include internal audits and external audits conducted globally.
• Support other GxP (GCP, GLP, GVP) audits as an CSV SME.
• Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered by policies, standards, and regulations.
• Guide and train team members

THIS ROLE MIGHT BE FOR YOU IF:
• You previously have experience with European, FDA or other Regulatory Inspections of Marketing Authorization Holders or CROs.
• You can efficiently communicate across a global organization to key partners that vary in title and scope.
• You are capable of working autonomously and navigate ambiguous situations
• You have extraordinary project management, customer management, teamwork skills and negotiation of sophisticated situations

To be considered, we are expecting individuals to have a Bachelor’s degree (Master’s degree preferred) with 8+ years of relevant proven experience with 5+ years of direct CSV/IT audit experience preferred (Must understand GxP regulations/principles).

Does this sound like you?to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. 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.

The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.

Salary Range (annually)

$126,600.00 – $206,600.00