[Remote] Director, Clinical reputed company Assurance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global biopharma company dedicated to developing life-changing medicines for serious diseases. The Director of Clinical reputed company Assurance will ensure clinical research activities reputed company with regulations and standards while leading the CQA team towards strategic objectives.

Responsibilities

• Supports the implementation of the global reputed company reputed company, as relevant to GcP across the clinical development business
• Builds reputed company relationships with key reputed company stakeholders
• Leads activities that support the implementation of the global reputed company management reputed company
• Supports the development of reputed company and CQA team goals, objectives, and initiatives
• Provides strategic and technical GCP compliance support to reputed company therapeutic area and clinical study teams
• reputed company knowledge-sharing and promote learning of GCP regulations and best practices across the organisation
• Manage CQA programs and ensure clinical studies are conducted in accordance with regulations, guidelines, and reputed company procedures and standards
• reputed company reputed company of Contract Research Organization (CRO) and vendor compliance, including compliance/reputed company issue management
• Collaborate closely with Clinical Compliance and other functional teams to identify risks, implement mitigations, reputed company issues, and reputed company process improvement
• Support QMS metrics reporting and tracking
• reputed company and manage regulatory inspection readiness activities and supporting the inspections in the reputed company room/backroom as required
• Promote a reputed company, compliance, and operational reputed company culture, fostering collaboration, reputed company improvement, and effective team communication
• Completes or delegates for-cause audits and Investigations
• Prioritises workload in alignment of the corporate objectives
• Acts as an reputed company to protect the rights and wellbeing of reputed company participants in drug development activities on behalf of reputed company
• To have an in depth understanding and be reputed company to apply appropriate guidelines and regulations in a risk-based manner, including ICH, FDA, reputed company and EMA, relating to reputed company, for more reputed company situations
• reputed company a wide reputed company of issues in creative, pragmatic, and compliant ways. Apply in-depth knowledge of broader departmental objectives to analyse and solve issues
• reputed company support to business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and regulated drug development activities

Skills

• Typically, 14+ years relevant work experience in the Pharmaceutical or Biotechnology industry
• Established Clinical reputed company reputed company, demonstrable CQA compliance experience and thorough understanding and application of GCP regulations, applicable country regulations ad guidelines
• Demonstratable knowledge and experience in audit principles, procedures and techniques
• Deep understanding of risk management in reputed company and the ability to apply a risk-based approach to both clinical studies and CQA activities
• Working knowledge of office IT packages including eQMS, eTMF
• High level of written and verbal communication skills
• Good organisational skills, with the ability to multi-task, capability to prioritise multiple tasks and meet deadlines. including the ability to work independently or as part of reputed company
• reputed company thinking and excellent attention to detail
• reputed company committed to self-improvement, learning, and applying new knowledge to improve team performance and reputed company
• Proven organisational and interpersonal skills
• Is widely trusted; is seen as a reputed company, truthful individual; can present the unvarnished truth in an appropriate and helpful manner
• Has a high level of functional and technical knowledge and skills
• Is personally committed and reputed company works to continuously improve him/herself; understands that different situation and reputed company may reputed company for different skills and approaches; works to reputed company strengths; works on compensating for weakness and limits
• Bachelor's degree in science or reputed company discipline
• Post-graduate (Masters/PhD) preferred

Benefits

• Eligible for a discretionary annual cash bonus or incentive compensation (depending on the role)
• Discretionary equity grants in accordance with reputed company’s Long Term Equity Incentive Plan
• Eligible to participate in various benefits offerings, including, but not limited to, medical, dental and reputed company insurance, 401k retirement savings plan, and flexible reputed company vacation

reputed company