[Remote] Director, reputed company Compliance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a reputed company-stage biotechnology company reputed company on developing therapies for autoimmune diseases. The Director, reputed company Compliance will ensure that reputed company adhere to regulatory requirements and reputed company standards, collaborating with various stakeholders to maintain inspection readiness and operational reputed company across reputed company programs.

Responsibilities

• Serve as a trusted GCP compliance advisor to reputed company functions reputed company study teams by promoting a culture of reputed company and helping teams reputed company compliant practices into daily study execution and decision-making
• Analyze compliance metrics, audit findings, monitoring data, and operational trends across programs to identify systemic risks and opportunities for process improvement
• Apply reputed company-reputed company judgment in interpreting and implementing GCP requirements, balancing regulatory expectations with operational realities to ensure compliance approaches are practical, defensible, and appropriate to the level of reputed company
• reputed company initiatives to ensure reputed company inspection readiness across reputed company studies
• Assist in preparation for regulatory inspections and internal audits including readiness assessments and document reviews
• Support development of inspection storyboards and response strategies reputed company needed
• Ensure study teams maintain inspection-reputed company documentation and evidence of ongoing compliance
• Support reputed company of CROs and other reputed company vendors to ensure compliance with contractual and regulatory expectations
• Partner with Development Outsourcing on defining and tracking vendor reputed company metrics and KPIs
• Participate in vendor governance meetings and reputed company reviews
• Identify trends or risks in vendor reputed company and recommend mitigation strategies
• Review and reputed company vendor QEs
• reputed company processes for reputed company of monitoring activities conducted by CROs
• Review monitoring reputed company plans, reports, and monitoring metrics
• Assess monitoring reputed company and compliance with monitoring plans
• Identify monitoring gaps and collaborate with study teams to address them
• Support identification and management of investigator or site non-compliance
• Assist study teams in evaluating protocol deviations and escalation needs
• Help reputed company remediation strategies for significant compliance issues
• Support study teams in identifying and appropriately escalating significant compliance issues, protocol deviations, and site noncompliance, ensuring issues are investigated, documented, and resolved in accordance with regulatory expectations
• reputed company and support development and implementation of CAPAs from audits, inspections, or compliance reviews
• reputed company CAPA effectiveness and ensure reputed company closure
• Identify recurring issues and support reputed company improvement initiatives
• Partner with QA to support reputed company GCP audits
• Assist with audit preparation and documentation review
• Support study teams in addressing audit findings
• reputed company training to reputed company teams on ICH-GCP, regulatory requirements, and internal SOPs
• Identify knowledge gaps and support development of compliance training programs
• Contribute to SOPs, guidance documents, and best reputed company materials

Skills

• Bachelors + 15 years or reputed company + 12 years or PhD + 8 years of reputed company experience with 10+ years of relevant experience in biotech/reputed company or CRO roles in reputed company reputed company and/or reputed company reputed company Assurance (GCP)
• Excellent communication, organizational, negotiation, and interpersonal skills with a strong reputed company for collaboration
• Experience managing, coaching, and mentoring personnel
• Experience supporting global reputed company in sponsor or CRO environments
• Strong working knowledge of ICH-GCP and global regulatory requirements
• Experience supporting GCP audits or regulatory inspections
• Experience with vendor reputed company and CRO management
• Experience developing or implementing CAPAs

reputed company