GCP Quality Improvement Lead (AD/Director)

Recruiter
Regeneron
Location
Tarrytown
Salary
Competitive
Posted
Jul 17, 2017
Closes
Jul 19, 2017
Industry
Executive Search
Employer Type
Direct Employer
Employment Type
Permanent
Hours
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, 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 Regeneron GCP Quality Improvement will have the primary responsibility to ensure that all Regeneron Global Clinical Development processes and procedures are aligned with current global regulations. This individual will partner with other members of the GCP Quality group to identify trends through metrics in order to diagnose and remediate systemic quality issues. Furthermore, the GCP Quality Improvement Lead will be responsible for serving as the GCP Subject Matter Expert (SME) whenever a new or revised controlled procedural document is written

Responsibilities:
  • Job duties may include but are not limited to:
  • Liaise with GCP Compliance & Process Teams to proactively identify opportunities to streamline and strengthen GCP process
  • Work closely with Regulatory Intelligence team to identify changes in global regulations affecting ccurrent Regeneron processes as they relate to GCP
  • Serves as GCP SME when SOPs are written or revised
  • Represent GCP expertise on cross-functional teams for GCP related process improvements resulting from new/revised regulations or guidance
  • Leads cross-functional rapid response teams for identified GCP process violations needing immediate remediation.
  • Interfaces: SOP & Process team; GCP Inspection teams; functional process owners, and CPMO Process improvement leads
  • Committees: standing members of GCP Quality Forum & SSN Committee
  • Other duties as 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 Regenerons 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.

Requirements:
Associate Director minimum of 10 years relevant experience; Director minimum of 12 years relevant experience. Level based on experience
  • Bachelors degree ( Masters degree preferred) with at least 10-12 years of relevant industry experience (Level commensurate with experience).
  • 6-8 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.
  • 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
  • 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
  • Strategic Thinking
  • Critical Thinking & Problem Solving
  • Integrity and Trust
  • Negotiating
  • Organizational & Political Savvy
  • Dealing with ambiguity & paradox