Associate Director - Quality Assurance and Compliance

2 days ago

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Strategic Consulting • Safety Management • Data Management • Biostatistics • Statistical Programming

501 - 1000

💰 Private Equity Round on 2021-04

Description

• The Associate Director, Quality Assurance and Compliance serves as the operational manager. • Direct, oversee, and manage all European clinical quality assurance activities. • Provide hands-on administration and management of Quality Systems. • Ensure compliance with Good Clinical Practices, Electronic Records/Signatures, and Quality Management System.

Requirements

• Bachelor’s degree required; science-related degree preferred. • 8+ years of GCP experience in an FDA, MHRA, EMA , and/or other competent authority regulated environment required. • Minimum of 5 years in the sponsor and/or Full Service CRO industry preferred. • At least 5 years of supervisory experience required. • Equivalent combinations of experience acceptable. • Demonstrated ability to lead by example. • Demonstrated skill for technical and supervisory leadership of staff required. • Solid understanding of global clinical research regulations required. • Knowledgeable in Quality Management System (QMS) design and requirements required. • Experience with implementation and management of GxP related electronic systems required.

Benefits

• Remote working • Flexible time off • Paid holidays • Medical insurance • Tuition reimbursement • Retirement plans