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What We Do

Care Access is a unique, multi-specialty network of research sites which operates as one connected team of physician investigators, nurse coordinators, and operations managers. Our goal is to engage every healthcare professional in clinical research and to make clinical trials a care option for every participant. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.

Who We Are

We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations.

Position Overview

The Vice President, Quality Assurance will be responsible for developing, implementing, and overseeing the quality assurance strategies and processes across Care Access. This senior executive role requires a visionary leader with a deep understanding of quality assurance principles, a track record of successful implementation, and the ability to inspire and lead a team of quality professionals.

What You'll Be Working On

Duties include but not limited to:

· 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.

Physical and Travel Requirements

· This is a remote position with up to 50% travel requirements. Length of travel will depend upon study requirements, staff needs, and company initiatives.

What You Bring

Knowledge, Skills, and Abilities:

· 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.

Certifications/Licenses, Education, and Experience:

· 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.

Benefits (US Full-Time Employees Only)

· 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.

· Culture of growth and equality

· 401k retirement plan

Diversity & Inclusion

We serve study participants and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success.

At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard study participant care with cutting-edge treatments and research. Our work brings life-changing therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the

physicians and caring for the participants in our clinical research studies.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

Care Access is unable to sponsor work visas at this time.

Employment Statement