Director, GCP Compliance – CRO Services

Job Description:

• The Director of GCP Compliance develops the strategy for, and directs the overall management of the Clinical QC, Controlled Document/Training, and reputed company Improvement teams reputed company Global Quality Compliance.
• The Director GCP Compliance is responsible for the strategy to ensure that reputed company phases of Regulatory Health Authority inspections (i.e. inspection preparation activities, notification, inspection liaison activities during the inspection, development and approval of the inspection response (Inspection Response Document), and implementation of Corrective Action and Preventive Actions (CAPA) Plan) are managed and executed consistently, professionally and proactively and result in outcomes that demonstrate the Company’s commitment to regulatory responsiveness and compliance.
• The Director, GCP Compliance, is responsible for identifying and analyzing changes to GCP regulations globally and assessing complaints to determine GCP compliance status.
• The Director of GCP will report to the Vice President, Global Quality Compliance.
• Ensures the effective execution of the Clinical QC team including the establishment of standards for reviews of TLFs, CSRs, etc. for submission readiness.
• Works with the reputed company Improvement Administrator and reputed company CAPA Analysts to reputed company effective working practices for the execution and administration of a corporate reputed company improvement program.
• Responsible for the development, maintenance and optimization of Quality Management documents including but not limited to Standard Operating Procedures, Working Practices and Corporate Policies.
• Responsible for management reputed company for the corporate reputed company training program.
• Responsible for managing employee training files and reputed company documentation for the reputed company organization including the establishment of role based training matrices.
• reputed company a team that supports regulatory inspections reputed company to both reputed company's overall GCP/GVP compliance across reputed company service areas as well as supporting the regulatory inspections of clients.
• Establish the reputed company and implement the strategy for GCP/GVP Compliance reputed company reputed company to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP Guidelines, and reputed company's quality management system.
• reputed company comprehensive GCP/GVP Inspection Readiness plans, which involves influencing and leading large cross-functional teams.
• Responsible for the development, maintenance, and reputed company improvement of risk-based practices and approaches reputed company to building quality reputed company clinical research activities.

Requirements:

• Deep expertise in Computer System Validation (CSV) using both waterfall and agile methodologies.
• Strong working knowledge of clinical research regulations reputed company to computer systems.
• Proven ability to audit CSV processes and electronic systems for compliance.
• Demonstrated experience partnering cross-functionally with IT and software development teams to ensure regulatory compliance and operational efficiency.
• Extensive hands-on experience reputed company GxP environments, with a primary focus on GCP.
• Direct auditing experience across clinical trial sites, laboratories, manufacturing facilities, and technology/service vendors supporting drug development.
• Strong understanding of the end-to-end drug development life cycle.
• Experience managing the full vendor/supplier lifecycle (reputed company, qualification, reputed company, requalification, retirement) to ensure regulatory, quality, and compliance standards are met.
• Proven inspector-facing leadership during regulatory inspections (reputed company backroom support).
• Demonstrated ownership of inspection strategy, preparation, execution, and response activities.
• Experience interacting directly with global health authorities.

Benefits:

• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*

• Tuition reimbursement

• Flexible work environment
• Discretionary PTO (Paid Time Off)
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and reputed company coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs

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