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Posted: Monday, January 8, 2018 5:38 AM

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 Senior GCP Regeneron Quality Management Lead (QML) is a key position that will manage the Quality Management Lead function. This individual will lead and mentor the other GCP Quality Management Leads and serve as the point of escalation for team based issues. He/she will work closely with the other members of the GCP Quality group to identify trends through metrics in order to diagnose and remediate systemic quality issues. Furthermore, the Senior GCP Quality Management Lead will be responsible for the strategy that will assure that assuring all aspects of the studies and programs are inspection ready at all times.

Responsibilities:

Job duties may include but are not limited to:

* Responsibilities: management of QML, assigns programs, ensures training, ensures standardization of ICH E6 R2 implementation across studies

* Escalation point for team based issues, identifying trends across programs

* GCP SME for training and implementation of complex GCP quality initiatives

* Review and approves QML TMF review plans

* Reviews and approves QRMP authored by QML

* Interfaces: Inspections team, Clinical Trial Management (CTM) and Therapeutic Area Project Manager (TAPM) Leadership, Quality Assurance and Auditing (QAA)

* Committees: standing member Suspected Serious Non-compliance (SS)N and GCP Committee

* Chairs Quality Forum

* Interface with Inspection Management Team to assure that study is inspection ready at all times, Monitoring group, Clinical Study Team, Clinical Compliance,

* Other duties as required

Requirements:

At least 15 years industry experience with at least 10 years in a relevant function

* Bachelor's degree ( Master's degree preferred) with 12+ years of relevant industry experience.

* At least10 years' experience working in either a clinical compliance group, QA Quality Management/Quality Risk Management function, or Clinical Development with expertise and/or transferrable skills with Good Clinical Practice and Regulatory Inspections.

* Expert knowledge of GCP

* Excellent communication skills and ability to work with people in all levels of the organization and externally.

* Demonstrated skills in taking initiative and working independently

* Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs.

* Demonstrated experience in driving Quality into the Clinical Trial Operations processes

* Self-motivated with the ability to work effectively in a dynamic environment

* Strong leadership with demonstrated ability to interface with senior leaders and different levels of the organization

* Good problem solving, written and verbal communication skills

* Ability to effectively manage multiple priorities with a sense of urgency

* Line Management skills and experience in mentoring and coaching direct reports

* Strong track record of project management, stakeholder management, collaboration skills and negotiation of complex situations

* Attention to detail and accuracy of work

Core Behavioral Competencies:

* Leadership

* Executive Presence

* Stakeholder Management

* Project Management

* Process Management

* Line Management

* Strategic Thinking

* Critical Thinking & Problem Solving

* Integrity and Trust

* Negotiating

* Organizational & Political Savvy

* Dealing with ambiguity & paradox

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.

SDL2017


Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

Source: http://www.jobs2careers.com/click.php?id=4643212796.96


• Location: Hudson Valley, Tarrytown

• Post ID: 34950617 hudsonvalley
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