Responsibilities:

• Support efforts to establish, maintain, and continually improve the Integrated Management System (IMS) (i.e., Information Security Management System and Quality Management System) ensuring compliance to ISO standards and regulatory requirements.
• Ensure organizational compliance to legal & regulatory requirements (e.g. ICH, 21 CFR Part 11, GxP, GDPR, etc.) and promote understanding, interpretation, and application of requirements. 
• Supports preparation for audits (sponsor, regulatory, certifying body).
• Facilitates drafting of audit responses
• Track quality metrics and KPIs
• Supports meeting preparation (Management Review, capabilities calls, etc.)
• Continually monitor and review quality records and documents within the eQMS
• Support external audits including remote audits and requests for information (RFI) ensuring accuracy of responses pertaining to the IMS.
• Support IMS document updates and ensure accuracy and adequacy of IMS documents.
• Support Training function and development and delivery of training.
• Promote quality, customer satisfaction, and improvement focus among the organization and perform quality improvement and analysis tasks as assigned.

Requirements:

• College graduate in scientific, medical, business, or related field, or equivalent experience
• 2-4 years’ experience in GxP industry
• Familiarity with current ISO 9001 and ISO 27001 standards
• Familiarity with 21 CFR Part 11, FDA, ICH, Privacy & Information Security requirements and standards, and GCP, cGxP requirements
• Experience with electronic Quality Management Systems (eQMS)
• Proficient in MS Office applications
• Excellent communication skills, ability to multitask, attention to detail, and organizational skills

Apply through this link