Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.
Responsible for supporting corporate internal and external audits, leading internal IT audits, and leading corrective action efforts to closure. Translate internal procedures, regulations and efficiency objectives into audit plans, schedule, execute, summarize and communicate audit outcome. Promote IT Department evolution in response to observations. This role reports to the Head of Planning and Compliance.
Essential Duties and Responsibilities include, but are not limited to, the following:
• Provide support during regulatory inspections, collaborate with various subject matter experts; participate in inspection readiness meetings; organize inspection role playing and preparation activities; perform routine updates to inspection readiness documents/tools.
• Create, communicate and maintain the internal IT audit schedule.
• Develop audit strategies, scope, procedures, tracking tools and templates based on applicable regulations, internal policies/procedures/work instructions, high-risk areas and departmental objectives.
• Lead, train and empower team to fully support internal and external audit lifecycle.
• Execute internal audits as scheduled, author audit reports and communicate audit outcome. Provide recommendations for gap closure and process improvements.
• Liaison with IT Management to assure that audit recommendations are workable and aligned with business and compliance objectives.
• Track audit responses and commitments to closure.
• Assist with tracking audit trends and group metrics.
• Lead continuous knowledge development regarding applicable regulations, best practices, tools, techniques and performance standards.
• Identify and escalate issues, risk, and roadblocks that may impact product quality, safety, information security, regulatory compliance or business continuity.
• Act as an Single Point of Contact, objective source of advice regarding regulations, best practices, regulatory guidance and audit risks.
Knowledge and Skills:
• Knowledge, understanding and applicability of 21CFR Parts 11, 211, SOX, Annex 11, MHRA, FDA and WHO data integrity guidelines.
• Ability to work effectively with different departments, personalities.
• Skilled in audit techniques and management.
• Knowledge of IT controls.
• Presentation skills.
• Skilled at using MS Office tools such as MS Word, Excel and PowerPoint.
• Leadership/management skills.
• Excellent organizational, interpersonal and leadership/teamwork abilities.
Education and Experience:
• Experience directly interacting with regulatory agencies, internal auditors, SOX auditors and Quality Assurance. Excellent communication skills.
• Bachelors Degree in science, computer science or related field.
• At least 7 years experience in an IT audit/compliance role (at least 5 years in FDA-regulated environment).
• Experience managing/ leading others during audit lifecycle.
• Auditor certification such as CISA a strong plus.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.