Associate Manager IT Compliance

Rensselaer, New York, US
Sep 10, 2018
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.

Summary: The IOPS (Industrial Operations and Product Supply) Associate Manager IT Compliance leads a team which is responsible for ensuring that the IOPS IT group is operating in compliance with regulatory requirements and Regeneron internal procedures as well as being the key contact between the IOPS IT and Quality Assurance groups.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Manages and supports the IT Compliance Team in prioritizing/scheduling their work load and conducting feedback/performance discussions with direct reports.

• Facilitates the IT Compliance Team in proactively supporting other IT groups (Infrastructure, enterprise applications, etc.) to ensure compliance with regulatory and corporate requirements.

• Ensures IOPS IT personnel are operating in compliance with regulations and procedures.

• Monitors and tracks IOPS IT Quality metrics on a daily basis.

• Provides IT Compliance Metric Reports to management on a weekly and monthly basis.

• Manages and/or assists IOPS IT personnel in writing/responding to deviations/events including detailed event investigation and root cause analysis/Change Controls/Document creation or update, etc.

• Evaluates, develops and modifies IOPS IT Policies and Standard Operating Procedures to meet regulatory requirements and obligations.

• Works closely with QA Validation to ensure IOPS IT systems are validated and maintained in a validated state.

• Represents IOPS IT and/or assists IOPS IT Subject Matter Experts (SMEs) during internal and external audits.

• Ensures that all IT compliance Operational Controls are in place and fit for purpose for IT systems including Disaster Recovery and Data Integrity.

• Ensures IT representation at Deviation/Event meetings/Change Control meetings.

• Works closely with Technical Training to ensure IOPS IT training is adequate and current.

Knowledge and Skills:

• Knowledge of and experience with Quality Management Systems.

• Knowledge of and experience with SDLC methodologies in a regulated environment.

• Excellent technical writing ability and communication skills.

• Working knowledge of utilizing a risk-based approach to documentation and/or experience with Quality Risk Management is strongly preferred.

• Knowledge of cGMP, 21 CFR Part 11, Annex 11, GAMP 5 strongly preferred.

• Excellent attention to detail and ability to adapt to new systems/technologies.

• Ability to deal with ambiguity and leverage experience and available information to guide decision making.

• Continuously drive to improve processes for improved performance.
Education and Experience:

• Requires BS/BA in related field; may substitute relevant industry experience for educational requirement.

• Requires a minimum of 8 years of relevant experience in a regulated environment, preferably in pharmaceutical/biotech industry.

• Experience leading or managing a team required.

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.