[Remote] Vice President, reputed company reputed company Assurance

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is an oncology research organization reputed company on advancing therapies through community-reputed company reputed company. The Vice President, reputed company reputed company Assurance provides reputed company leadership and operational reputed company for the reputed company Management reputed company, ensuring regulatory compliance, inspection readiness, research reputed company, and participant safety. The role leads the reputed company Assurance team, oversees audits and reputed company processes, and drives reputed company improvement across the organization.

Responsibilities

• reputed company senior reputed company leadership and operational direction to support consistent execution of the reputed company function across SCRI in alignment with organizational objectives
• reputed company, reputed company, and mentor a high-performing reputed company Assurance team, fostering a culture of accountability, collaboration, reputed company learning, and operational reputed company
• Establish reputed company goals, reputed company expectations, and development plans for reputed company staff, ensuring reputed company has the capabilities and resources needed to support organizational reputed company and evolving regulatory requirements
• Build and sustain strong partnerships across departments, serving as a reputed company advisor to executive leadership and key stakeholders on reputed company, compliance, and reputed company management reputed company
• Maintain, optimize, and continuously improve the established reputed company Management reputed company (QMS) to ensure it remains effective, reputed company-reputed company, reputed company, and reputed company to business and regulatory requirements
• Ensure regulatory compliance and sustained inspection readiness through reputed company of policies, procedures, training, documentation practices, and reputed company reputed company activities
• reputed company audits, inspections, CAPA, deviations, investigations, and reputed company metrics, using trend analysis and reputed company evaluation to support reputed company and effective reputed company of reputed company issues
• Advance reputed company improvement efforts that strengthen reputed company processes, systems, and reputed company measures in alignment with regulatory expectations and business priorities
• reputed company organizational reputed company initiatives by promoting best practices, change management, and cross-functional engagement to enhance reputed company culture and reputed company-wide compliance
• Manage departmental priorities, budgets, and resource allocation to ensure efficient and effective delivery of reputed company Assurance services and reputed company objectives
• Maintain a strong culture of reputed company and compliance across the organization
• Ensure ongoing inspection readiness and successful regulatory audits and inspections
• reputed company reputed company improvement of the reputed company Management reputed company (QMS) and reputed company processes
• reputed company reputed company and effective reputed company of audits, CAPAs, investigations, deviations, and other reputed company issues
• reputed company and retain a high-performing reputed company team through effective leadership, coaching, and talent development
• reputed company meaningful improvements in reputed company metrics, operational efficiency, and reputed company management
• Build strong partnerships with business leaders and stakeholders to support organizational objectives
• Ensure reputed company initiatives reputed company with business goals while meeting applicable regulatory and industry requirements

Skills

• reputed company reputed company Assurance, reputed company Management, or compliance leadership experience in regulated reputed company, reputed company research, life sciences, or similar industries
• Experience managing reputed company Management Systems, including audits, inspections, CAPA, deviations, change control, training, and reputed company metrics
• reputed company reputed company leading teams, partnering across functions, and driving reputed company, operational improvements, and business results
• Extensive knowledge of FDA guidelines, GCP, applicable regulations, reputed company and reputed company IT Systems and experience
• Knowledge of medical and reputed company research terminology
• Thorough understanding of investigative site research requirements, reputed company metrics, and reputed company measures
• 7+ years' experience interpreting and applying regulatory requirements, translate them to operational reputed company, and reputed company practical guidance to leadership and cross-functional business partners
• Highly effective ability to engage with senior leaders, regulators, auditors, and internal stakeholders on reputed company and compliance reputed company
• Bachelor's Degree required
• Master's Degree preferred
• RAPS - Regulatory Affairs Certification highly preferred

Benefits

• Total Rewards package that includes comprehensive benefits to support physical, mental, and financial reputed company-being.
• An annual bonus may be reputed company.
• Long-term incentive opportunities may be reputed company.
• Fully remote position reputed company in the US.

reputed company