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Director or Senior Director, Global Inspection Readiness

Employer
Labcorp
Location
Maidenhead, United Kingdom
Salary
Competitive
Start date
19 Oct 2021
Closing date
27 Oct 2021

View more

Discipline
Clinical Research
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details


This position is a leadership role highly visible within the organization required to work with all levels of management internal to Labcorp Drug Development (up to and including Executive Leadership Team). This position will oversee and drive the culture of Trial Master File (TMF) Inspection Readiness and partner with the organization on improvement initiatives.

This position has responsibility for strategic direction, delivery and oversight of the Global Operational Inspection Readiness group. This position and department will be aligned as partners to the functional areas of the CDCS business to ensure appropriate TMF oversight and solution partnering. Driving TMF excellence within the organization through execution of key activities, improvement methodologies and governance forums. Of importance are the requirements to lead, strategize, partner and influence across various functions and locations.

Provides TMF specific regulatory compliance advice, guidance and support to internal CDCS teams and functions and collaborating with other internal stakeholders (e.g; Legal) for proactive interactions and quality management.

Support inspection readiness planning and remediation activities for studies proactively identified as high risk.
Education/Qualifications:
  • University/college degree, BA/BS (life science preferred) or equivalent experience
Experience:
12-15 years experience in a regulated environment (e.g. GCP) in roles of a related discipline (e.g. Quality Assurance, Regulatory, Operations, Project Management), with 10 years supervisory experience or equivalent experience
  • Proven ability to manage managers and business leaders in a global clinical operations setting
  • Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
  • Thorough knowledge of global clinical development processes, standards and budgeting
  • Knowledge of the drug development process from the perspective of a contract research organization
  • Experience in quality improvement methodologies such as FMEA, Six Sigma or other similar BOK
  • Demonstrated ability to lead and influence/guide at all levels
  • Demonstrated ability to successfully interact with Executive leadership

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
Maidenhead
SL6 3QH
United Kingdom

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