associate director validation, site quality

Essential for the role:

• Appropriate scientific degree with extensive experience (5-10 years) of working with validation, in a pharmaceutical GMP environment, preferably within a pharmaceutical development organization
• Extensive experience from working with all types of validation including, equipment, automation and IT system.
• A broad and comprehensive understanding of Quality Systems and GMP and good knowledge and reputation in the QA arena and specifically in GMP matters
• A comprehensive understanding of the pharmaceutical/drug development process is essential. A detailed scientific understanding of the Product types being supported is desirable
• Experienced in leading projects, making decisions, acting courageously and communicating with conviction and inspiration and in building excellent relationships both internally and with external suppliers or service providers
• Understanding of Supply Chain processes is desirable

Soft skills:

• You thrive when you work independently, when leading projects and take pride in structuring your day, knowing that the diverse workload can change the schedule with little notice.
• You are a problem solver who can look at solutions in a pragmatic way – coming up with creative solutions whilst still following our strict regulations.
• Excellent team working and networking skills
• Demonstrates independent judgement and uses risk management in complex situations
• Capable of making decisions, acting courageously and communicating with conviction and inspiration
• Demands excellence (sets high bar) and delivers
• A good communicator with experience of interacting effectively across interfaces

As an Associate Director, you will develop and maintain in-depth knowledge of the quality regulations and guidelines applicable to your area. You will mentor and support junior colleagues, build strong customer relationships, and participate in GxP audits/initiatives. You will also be responsible for developing and approving GMP documentation and QA risk assessments, providing Quality input into business improvement projects, and be part of external Regulatory Authority GMP inspections. You will work closely with the leadership teams of our customers to set strategic direction for quality within that area, maintaining quality oversight and driving continuous improvement.

Most appreciated in the role is the ability to lead projects, to improve processes or ways of working and support different functions with your subject matter expert knowledge. Working in a development environment makes your role versified and enables lifelong learning in everyday tasks.