Manager, IT Compliance

Location
Tarrytown, New York, US
Posted
Sep 14, 2018
Ref
13984BR
Required Education
Masters Degree/MBA
Position Type
Full time
Position Summary

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.

Summary:
The Compliance Manager is responsible for developing and administering the infrastructure qualification program, leading investigations/responses/corrective actions related to IT GxP incidents and implementing a risk management program. The incumbent will support the project management and change management processes to assure that any changes to the infrastructure are properly assessed and testing/controls are completed as required. Additionally, the manager will work to integrate risk a management approach throughout the IT organization and perform performance monitoring, as appropriate. This position reports to Director of IT Compliance.

Responsibilities:

• Develops, owns and administers risk-based Infrastructure Qualification program.

• Implement procedures, work instructions and templates to drive infrastructure qualification, risk management and incident tracking activities.

• Support GxP Project Management and Change Management process.

• Lead, train and empower team to fully support infrastructure qualification, risk management and incident tracking/closure.

• Develops, owns and administers IT risk management program. Works closely with IT functional groups to document risks, mitigations/controls and tracking.

• Integrate risk with other IT Compliance functions such as auditing, qualification and change management processes.

• Support Incident/CAPA tracking, communication of issues within IT, responses, corrective action identification and closure.

• Develops and administers IT SOP Program. Works closely with IT functional groups to implement efficient IT Operating Procedures and Work Instructions.

• Support IT GxP Training Program. Works closely with IT training function to ensure effective GxP training curriculums.

• Develop Key Performance Indicators (KPI's) to identify process improvements, performance measurements, and compliance risks.
Knowledge and skills:

• Comprehensive knowledge of IT infrastructure qualification requirements in an FDA regulated setting. Ability to leverage risk determination to scale qualification and control approach to balance efficiency and compliance.

• Knowledge, understanding and applicability of 21CFR Parts 11, 211, Annex 11, MHRA, FDA and WHO data integrity guidelines.

• In depth knowledge of risk assessment techniques.

• Ability to work effectively in a challenging, fast paced, regulated IT environment. Ability to resolve differing perspectives with effective negotiation and diplomatic skills while assuring internal procedural requirements are upheld.

• Written, verbal and interpersonal communication skills and the ability to effectively interact with all levels to establish and maintain group objectives.

• Ability to manage multiple projects and changing priorities with organizational and time management skills. Demonstrate a positive proactive approach to drive projects/tasks to completion.

• Strong understanding of IT processes such as configuration management, change management, document management, risk assessment, training, infrastructure qualification and audit preparations.

• Ability to converse with and influence developers, IT, clinical, quality assurance and information security disciplines.

• MS Office tools such as MS Word, Excel, and PowerPoint.

Requirements:

• Bachelor's Degree in science, computer science or related field.

• At least 7 years experience in an IT compliance or related role in a FDA regulated environment.

• In-depth knowledge of pharmaceutical cGMPs, EMA, Part11, IT best practices, FDA Guidance.

• Experience managing/ leading others in an FDA regulated setting.

• Significant experience interacting with internal/external auditors.

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.

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