Manager, Computer System Validation (CSV) Auditing

Regeneron Pharmaceuticals

6d • Onsite

About The Position

The Manager, QA-CSV (Quality Assurance - Computer System Validation) Auditing is a key position in the Global Development Quality Assurance (GDQA) group and will provide guidance and leadership for the CSV Auditing group. This individual will build strategic partnerships and implement risk-based quality auditing activities across GDQA. We feel the Manager, CSV Auditing, should apply their expertise in GxP, CSV and international regulations to the auditing process to independently address a variety of CSV compliance issues. We believe the person in this role will 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 the person in this role 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. The individual in this role is considered a top subject matter expert who possesses an advanced knowledge of the Global Development Organization. One of the key objectives for the 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 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 a 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 optimally 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 phenomenal project management, customer management, teamwork skills and negotiation of sophisticated situations.

Requirements

• Bachelor’s degree (Master’s degree preferred)
• 6+ years of relevant proven experience
• 4+ years of direct CSV/IT audit experience preferred (Must understand GxP regulations/principles)

Nice To Haves

• Experience with European, FDA or other Regulatory Inspections of Marketing Authorization Holders or CROs.
• Optimally communicate across a global organization to key partners that vary in title and scope.
• Capable of working autonomously and navigate ambiguous situations.
• Phenomenal project management, customer management, teamwork skills and negotiation of sophisticated situations.

Responsibilities

• Scheduling, preparing, conducting, reporting and follow-up on routine and directed CSV audits in 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 a CSV SME.
• Interpret policies, standards, and regulations, and evaluate potentially critical problems not covered by policies, standards, and regulations.
• Guide and train team members.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees