Manager IT Quality Systems

Rensselaer, New York, US
Sep 29, 2018
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
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, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases.

Summary: Manages functions related to IT Quality Systems including relationships with internal customers (both business and technical) for the QMS (Process Compliance) and the EDMS (DocCompliance). Works with internal and external technical resources to ensure business needs are met. Also responsible for coordination and tracking of QUMAS-related projects.

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

• Manages and develops IT Quality System direct reports
o Ensures new QS employees are on-boarded and trained; oversees development of training tools and resources related to administration of Quality Systems QMS, EDMS
o Assigns and oversees projects for, manages workload of, and provides direction to Qumas and QS Analysts
o Reviews Analysts' work and assists with reviews as necessary
o Manages and grows the roles and responsibilities of the QS group; further develops Analyst's skills and understanding of content, and promotes their services to other groups at IOPS
o Identifies the strengths and interests of direct reports and applies them to opportunities aligned with the group's plans and mission

• Provides management support for the development and implementation of QUMAS-related programs/projects and changes.

• Manages day-to-day client interactions and expectations for DocCompliance and Process Compliance programs.

• Ensures that project documents are complete, current, and correct.

• Effectively manages project scope by ensuring that any changes to scope are documented and approved.

• Manages, analyzes and defines business processes in both the "current state" and "desired state".

• Facilitates communication between vendors, integrators, developers and stakeholders to ensure that customer requirements are translated into design specifications and appropriate testing efforts.

• Follows the methodologies and standards for IT project documentation and implementation, which includes guidelines, procedures, standards, and monitoring for organizational compliance.

• Develops proposals and strategies related to future-planning and growth of the group.

• Keeps management informed of decisions, overall strategy, and project status.

Knowledge and Skills:

• Knowledge of 21 CFR Part 11, Annex 11 Regulations and Good Manufacturing Practice (GMP)

• Must show strong judgment and time management skills

• Ability to communicate at all levels with clarity and precision both written and verbally

• Excellent interpersonal skills with strong customer service focus

• Ability to maintain integrity and honesty at all times

• Continuously drive to improve processes for improved performance

• Handle issues appropriately and with a sense of urgency

• Identify and effectively communicate risks

• Ability to problem solve and identify root cause

Education and Experience:

• BS/BA in related field and 6+ years of relevant experience required.

• Experience in pharmaceutical or biotech industry required.

• Requires previous management/leadership experience.

• 2+ Years QMS and EDMS configuration experience required.

Title level will be determined based on skills and experience relevant to the role.

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, disability status, protected veteran status, or any other characteristic protected by law.