Care Access is hiring a
Vice President Quality Assurance

Summary

Join our team as a Vice President, Quality Assurance at Care Access, where you will develop and implement quality assurance strategies, lead a team of quality professionals, and ensure compliance with industry standards.

Requirements

• Expert knowledge of ICH GCP and understanding of international regulatory requirements
• Strong organizational skills, ability to multi-task, attention to detail, self-starter and ability to prioritize
• Strong communication, negotiation and presentation skills
• Proven ability to manage and develop people
• Degree in biomedical sciences, or related scientific discipline, or a combination of education and experience in health sciences industry
• 15+ years in clinical research within the pharmaceutical industry, CRO, site network or regulatory authority, with at least 10 years in clinical quality assurance/quality management or related area of responsibility
• Experienced with auditing clinical vendors and investigator sites
• Experienced in hosting / managing regulatory inspections

Responsibilities

• Develop and implement a comprehensive quality assurance strategy for clinical research in alignment with GCP and regulatory requirements
• Lead and manage the Quality Assurance department, ensuring alignment with overall business strategy and compliance with industry standards, setting clear objectives and fostering a culture of quality, compliance, and continuous improvement
• Collaborate with other senior leaders to integrate quality assurance seamlessly into all operations
• Support other functions in activities as appropriate
• Oversee the development and implementation of quality assurance policies, procedures, and standards
• Maintain robust quality management systems (QMS) to ensure compliance with GCP, ICH guidelines and applicable regulatory requirements
• Plan, conduct and oversee internal audits of sites, systems and processes
• Lead the preparation for and management of external regulatory audits and inspections
• In partnership with other operations, develop and implement risk management strategies to identify, assess, and mitigate quality-related risks across the organization
• Guide the organization in proactive quality risk management and facilitate the resolution of quality issues
• Establish key performance indicators (KPIs) to measure effectiveness of quality assurance activities and initiatives
• Provide regular reports to executive leadership on trends and improvement areas
• Serve as primary point of contact for quality assurance matters with sponsors, CROs and regulatory bodies
• Stay current with industry trends, regulatory changes, and advancements in clinical research

Benefits

• PTO/vacation days, sick days, holidays
• 100% paid medical, dental, and vision Insurance. 75% for dependents
• HSA plan
• Short-term disability, long-term disability, and life Insurance