Associate Director, Quality Assurance

ESSENTIAL JOB FUNCTIONS:
*Provide Quality Assurance leadership and support within allocated Region, liaising with the Senior Director, Global Quality Assuranc
*Deputise for the Senior Director, Global Quality Assurance for delegated projects or during absence
*Ensure sufficient Quality Assurance resource is available within allocated Region to cover planned auditing activities
*Ensure Quality Assurance resource is available for driving and providing input into process improvement initiatives generally, and specifically within own Region
*Line manage Quality Assurance personnel within allocated area, ensuring appropriate development and training of individuals
*Provide assistance with the maintenance of the global Quality Assurance System
*Provide assistance in assuring Senior Management of the effectiveness of the Quality Assurance System and the quality of the deliverables
*Assist in the provision of QA review of Policies, SOPs, Working Guidelines and Associated Documents prior to approval
*Drive and input into process improvement initiatives across the company
*Provide input into the management of a global audit strategy and Quality Assurance function
*Review the Quality Assurance processes, and associated documentation
*Ensure compliance with the global audit schedule encompassing both contracted and internal audits
*Organise and participate in audits across global operations
*Provide signatory approval for audit plans, reports and certificates
*Input into the preparation of reports to Senior Management documenting audit activities, metrics, findings and resolutions; and raise significant issues of non-compliance
*Provide training for less experienced Quality Assurance personnel, co-auditing as necessary
*Liaise with and provide supervision for contract auditors in Europe
Promote quality principles throughout the Group
*Manage, host and support sponsor audits and Regulatory Authority inspections
*Provide a Quality Assurance consultancy service for questions and issues raised by personnel

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
*At least 7 years Quality Assurance and ICH-GCP auditing experience in Europe; auditing experience in United States preferred
*At least 2 years experience in conducting systems and process audits
*At least 2 years management experience
*Strong knowledge of ICH GCP, FDA Code of Federal Regulations and other applicable regulatory authority laws and guidelines
*Experience in hosting and responding to sponsor audits and regulatory authority inspections preferred
*Degree in Health or Life Sciences
*Excellent knowledge of the English Language
*Excellent organisational, interpersonal and communication skills
*Ability to work effectively with sponsors and across internal departmental lines
*Ability to develop and present educational programs and/or workshops
*Capable of working in a team or independently.