Associate Director Quality Assurance
GxPeople is currently working with a global client who is seeking an Associate Director Quality Assurance to join their team in USA.
The Associate Director of Quality Assurance is responsible for developing, maintaining and improving the Global Quality Management System under the direction of the VP, Global Quality, including management of quality systems such as document control, training, CAPA, deviation, and change control. The role also involves implementing and managing the GCP Quality Assurance program for the conduct of clinical trials, and managing and/or performing audits of studies, programs, processes and systems to assure compliance with appropriate cGMP/GDP/GCP/GLP/GVP/computer validation regulations, guidelines and standards. The ideal candidate should have a thorough understanding of all practices, however the primary focus for this role will be on GCP and GLP and will also provide secondary support to the manufacturing and supply chain process as needed.
- Oversee manufacturing processes and ensure compliance against company objectives and the regulatory agency requirements.
- Establish and carry out procedures, and review GXPs standard documents
- Supervise the CAPA, deviations and change control systems, implement the GCP Quality Assurance program and carry out audits.
- Implement and supervise the GxP training program and maintain records.
- Lead and develop the team by having regular meetings and implementing performance measures.
- Provide support in managing the Quality Assurance budget.
Qualifications and Experience
- Bachelor’s degree in pharmacy or or related scientific field.
- Understanding of cGXPs, FDA and ICH regulations’ implementation.
- GCP Quality Assurance management experience within pharmaceutical or biotech industries.
- Experience in Quality Assurance or Regulatory Compliance (minimum 7 years), experience in cGxP auditing (minimum 5 years), and experience in project or resource management (minimum 3 years).
- Knowledge of QA issues within the pharmaceutical industry and knowledge of regulatory compliance.
- Management and leadership skills to be able to develop the team and achieve company’s targets.
- Good understanding of quality systems used in pharmaceutical and biotech industry.
- Up to 25% availability to travel
For more information or, if you’d like to be considered for this position please call us on +44 20 3637 4393 or email email@example.com.