Primary purpose and function of this position:
The Compliance and Document Control Manager is responsible for:
1. Combination Product implementation and maintenance of the Quality Management System (QMS), and to assure continuous compliance with all quality guidance’s, regulations and best practices.
2. Management of the Documentation Center.
Major duties and responsibilities:
· Ensure company wide compliance, Quality Management System Deviations, Complaints, Change Controls, ECO, CAPA, Risk Assessments, Internal Audits, External Audits, Vendor Selection
· Issuing, Reviewing and Approving on behalf of QA applicable types of Controlled Documents, Change Controls, CAPAs, Complaints and Deviations
· Participate in outsourcing vendor evaluation and selection.
· Oversee vendor auditing, qualification and vendor performance for all Combination Product related vendors.
· Lead the Internal audit program which is communicated to cross company departments and performance of internal audits.
· Ensuring that the Internal audits are performed and reported as scheduled.
· Represent Quality Assurance on cross-functional teams, as appropriate, and serve as a resource for quality and compliance questions, issues, including providing guidance based on current
· Managing gap analysis and risk assessments processes activities in relation to regulatory guidances and best practices.
· Managing the Document Control Center: Controlled document lifecycle management and Periodic review, Hard copy and Archiving management, Logbook issuance and tracking. Training records management.
· Assisting the implementation of the retention policy and List of Records.
· Any other task assigned by direct manager.
Reports To: Director ofQuality Compliance
Education and Knowledge Requirements:
· Bachelors degree in Life science or relevant degree is required.
· Familiar with relevant regulatory requirements, Strong understanding and interpretation of GxP and ISO 13485 best quality practices in regards to combination products.
· At least 5 years experience in maintaining Quality Management Systems (Must have experience working in the Pharmaceutical or Biotechnology industry Quality Systems and Medical Device).
· Good computer skills including full control of Microsoft Office application.
· Fluent in Hebrew and English (writing and speaking).