Director, IT Quality

Location
Tarrytown, New York
Posted
Apr 19, 2018
Ref
10988BR
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
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.

The IT Quality Associate Director/ Director will be responsible for building, implementing and managing the IT Quality function including IT Document Control, IT Change Management and IT training. The incumbent will provide strong, reliable leadership while promoting customer focus, risk-based decision making, continual improvement and inspection readiness within the IT organization. IT Quality processes will be developed/re-engineered to be scalable, repeatable, flexible and lean to support a variety of regulatory and IT customer needs.

Responsibilities:
• Manage team of resources to develop, establish and maintain compliant and efficient IT Quality group in support of Regeneron IT.
• Oversee development and implementation of lean IT policies, procedures, work instructions and templates.
• Develop and oversee IT training function.
• Manage the IT Document Control function. Assure quality standards for new Policies/Procedures/ Work Instructions/ Templates are upheld.
• Develop and oversee IT change management program. Work closely with Quality Assurance to integrate processes and assure compliance needs are addressed.
• Develop, track and regularly report metrics around key performance indicators (KPIs).
• Monitor regulations for updates that impact IT department and implement related changes.
• Lead evolution of IT Quality function.

• Thorough understanding of regulatory requirements related to IT Biopharmaceutical company operations.
• Familiarity with GAMP5, ICH, FDA Guidance documents and ITIL.
• 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.
• Experience identifying and implementing efficiencies and improvements in Pharma IT setting.
• Knowledge of different SDLC models and related regulatory requirements.
• Prior development and implementation of IT controls.
• Written, verbal and interpersonal communication skills and the ability to effectively interact with all levels to establish IT Quality function
• 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, training and governance.
• Ability to converse with and influence developers, IT, software, clinical, regulatory, internal auditor and quality assurance disciplines.

Education and Experience:
• Bachelors Degree in science, computer science or related field.
• At least 12 years experience in an IT Quality or related role in a pharmaceutical environment. Significant experience in another regulated industry can comprise a portion of the 12+ years experience required.
• In-depth knowledge of pharmaceutical cGMPs, SOX, EMA, IT best practices, FDA Guidance.
• Experience leading a team of 6 or more resources and managing department budget.
• Significant experience interacting with internal/external auditors/regulators.
• CISA or similar certification a 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.

Requisition Number: 10988BR