Dir of QA / Reg Compliance - eClinical Software

DESCRIPTION:

• Provide guidance, interpretation, support, training, and key input to staff on interpretation of GCP regulations, guidelines, quality system requirements, corporate standards, and policies.
• Direct the development and implementation of training on new / enhanced SOP management processes.
• Provide expertise as needed to customers during the development of new SOPs. 
• Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
• Act as customer liaison during audits of SOP Management.

REQUIREMENTS:

• Must have GCP experience
• Must have experience coming from clinical software background ( EDC, ePRO, IVRS )
• Bachelors degree in life sciences with 7-10 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience.
• A minimum of 3 years of management experience
• Experience in SOP Management / Document Control and SOP writing
• Knowledge of process improvement and project management methodologies.
• Strong technical / medical writing skills including knowledge of SOP writing.