<p>Location: Remote, US</p><br/><p>Employment Type: Full-time Employment</p><br/><p>Team: Quality Assurance</p><br/><div><b style="font-size: 13pt">What We Do</b><span style="font-size: 13pt">&nbsp;</span></div><div><span style="font-size: 12pt">Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies.&nbsp;</span></div><div><span style="font-size: 10.5pt">&nbsp;</span></div><div><b style="font-size: 13pt">Who We Are</b><span style="font-size: 13pt">&nbsp;</span></div><div><span style="font-size: 12pt">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.&nbsp;&nbsp;</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">Position Overview</b><span style="font-size: 13pt">&nbsp;</span></div><div><span style="font-size: 12pt">The Senior Quality Assurance Auditor role is a key member of the Quality Assurance team and provides support to all aspects of the Quality functions across the business. The role will support QA Management in assuring quality throughout the Company and will promote continual improvement processes to ensure all systems and procedures undertaken by Care Access are compliant with ICH-GCP Guidelines, and other applicable regulatory </span><a href="http://requirements.This" style="font-size: 12pt" class="postings-link">requirements. This</a><span style="font-size: 12pt"> role encompass a broad spectrum of activities, ranging from auditing systems and processes to collaborating with stakeholders and contributing to the organization's overall quality and regulatory compliance objectives.&nbsp;</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><b style="font-size: 13pt">What You'll Be Working On</b><span style="font-size: 13pt">&nbsp;</span></div><div><b style="font-size: 12pt">Duties include but not limited to:</b><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 16px">Conduct audits on quality systems and processes to ensure adherence to company policies, quality criteria, and applicable regulatory requirements and industry standards.&nbsp;</span></div><div><span style="font-size: 16px">Internal routine audits and training to ensure consistency and compliance of Operations across all sites.&nbsp;</span></div><div><span style="font-size: 16px">Complex audits, such as For-Cause audits, or process/ system audits at short notice.&nbsp;</span></div><div><span style="font-size: 16px">Preparation and hosting external audits (e.g. conducted by Care Access Clients) and Regulatory Authority Inspections.&nbsp;</span></div><div><span style="font-size: 16px">Act as the QA SME for Quality Issues. Attend cross-functional meetings and support Operational Compliance Teams with root cause analysis investigations (as required).&nbsp;</span></div><div><span style="font-size: 16px">To work with Care Access personnel to improve and implement globally working practices and systems, in compliance with GCP and appropriate regulations to ensure best practices are achieved.&nbsp;</span></div><div><span style="font-size: 16px">Act as the SME for business process improvement projects (as required).&nbsp;</span></div><div><span style="font-size: 16px">Review existing quality standards and actively contribute to the development of programs aimed at enforcing and enhancing these standards.&nbsp;</span></div><div><span style="font-size: 16px">To be an active part of the Quality Assurance team and work with the other members to plan and to manage the business, the culture, the values and the wellbeing of the company and its people so that the commercial objectives are achieved.&nbsp;</span></div><div><span style="font-size: 16px">To develop Quality systems, processes and procedural improvements that deliver increased efficiency and other benefits.&nbsp;</span></div><div><span style="font-size: 16px">Investigate, analyze, and ensure the accuracy of information in quality data collection tools, contributing to reliable data-driven decision-making.&nbsp;</span></div><div><span style="font-size: 16px">Where requested by QA Management, provide effective training, coaching and mentoring, to junior members of the Quality Assurance department.&nbsp;</span></div><div><span style="font-size: 16px">Where required, to peer review audit reports.&nbsp;</span></div><div><span style="font-size: 16px">Conduct reviews of Care Access formal procedures to ensure alignment with quality standards and regulatory requirements.</span></div><div>&nbsp;</div><div><b style="font-size: 13pt">Physical and Travel Requirements</b><span style="font-size: 13pt">&nbsp;</span></div><div><span style="font-size: 16px">This role requires up to 50% travel requirements. Length of travel will depend upon study requirements, staff needs, and company initiatives.&nbsp;&nbsp;</span></div><div>&nbsp;</div><div><b style="font-size: 13pt">What You Bring</b><span style="font-size: 13pt">&nbsp;</span></div><div><b style="font-size: 16px">Knowledge, Skills, and Abilities:</b><span style="font-size: 16px">&nbsp;</span></div><div><span style="font-size: 16px">Knowledge of the Clinical Trial Process&nbsp;</span></div><div><span style="font-size: 16px">Knowledge of working to Quality systems and procedures in a regulated environment&nbsp;</span></div><div><span style="font-size: 16px">Knowledge of international GCP regulations and regulatory inspections&nbsp;</span></div><div><span style="font-size: 16px">Excellent analytical and communication skills and a proven track record of interacting with customers and/or suppliers&nbsp;</span></div><div><span style="font-size: 16px">Computer skills in Microsoft Office applications are essential.&nbsp;&nbsp;</span></div><div><span style="font-size: 16px">Be highly organized with a focus on quality and detail&nbsp;</span></div><div><span style="font-size: 16px">Self-motivated with a high level of initiative&nbsp;</span></div><div><span style="font-size: 16px">Open and clear communicator with excellent interpersonal skills&nbsp;</span></div><div><span style="font-size: 16px">Ability to mentor junior staff&nbsp;&nbsp;Ability to work in a proactive and reactive environment&nbsp;</span></div><div><span style="font-size: 16px">Ability to work with complex and difficult situations alone&nbsp;Good problem solving skills&nbsp;</span></div><div><br></div><div><b style="font-size: 16px">Certifications/Licenses, Education, and Experience:</b><span style="font-size: 16px">&nbsp;</span></div><div><span style="font-size: 16px">BSc Degree (life science) or equivalent qualification&nbsp;</span></div><div><span style="font-size: 16px">Minimum five years’ experience in Clinical Quality Assurance within a CRO or Pharma organization or equivalent environment</span></div><div><span style="font-size: 16px">Experience of performing clinical quality audits e.g. investigator site audits, process/ system audits, vendor audits.</span></div><div><span style="font-size: 16px">Experience in validation of Computerized Systems would be an asset.&nbsp;</span></div><div><span style="font-size: 16px">Experience of regulatory inspections e.g. MHRA, FDA&nbsp;&nbsp;Experience of sponsor/CRO audit process&nbsp;</span></div><div><br></div><div><b style="font-size: 13pt">Benefits (US Full-Time Employees Only)</b></div><div><span style="font-size: 16px">PTO/vacation days, sick days, holidays.&nbsp;&nbsp;</span></div><div><span style="font-size: 16px">100% paid medical, dental, and vision Insurance. 75% for dependents.&nbsp;</span></div><div><span style="font-size: 16px">HSA plan&nbsp;Short-term disability, long-term disability, and life Insurance.&nbsp;&nbsp;</span></div><div><span style="font-size: 16px">Culture of growth and equality&nbsp;401k retirement plan&nbsp;</span></div><div><br></div><div><b style="font-size: 13pt">Diversity &amp; Inclusion</b><span style="font-size: 13pt">&nbsp;</span></div><div><span style="font-size: 12pt">We serve patients 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.&nbsp;&nbsp;</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">At Care Access, every day, we are advancing medical breakthroughs. We’re uniting standard patient 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&nbsp;</span></div><div><span style="font-size: 12pt">physicians and caring for patients.&nbsp;</span></div><div><span style="font-size: 12pt">&nbsp;</span></div><div><span style="font-size: 12pt">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.&nbsp;</span></div><div><span style="font-size: 11pt">&nbsp;</span></div><div><span style="font-size: 12pt">Care Access is unable to sponsor work at this time.&nbsp;</span></div><div><br></div><div><b style="font-size: 13pt">Employment Statement</b></div><div><span style="font-size: 11.5pt">Care Access complies with all employment laws and regulations with respect to its employment practices, terms and conditions of employment, and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate, under any circumstances, the use of any form of forced or involuntary labor, child labor, or human trafficking. This extends to suppliers, partners, or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.</span></div>

Location: Remote, US

  

Employment Type: Full-time Employment

  

Team: Quality Assurance

  

 **What We Do**  

Care Access is delivering the future of medicine today! Care Access has a
revolutionary model that breaks down traditional barriers to clinical trials
that limit participation among physicians and patients to 3%. 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 Senior Quality Assurance Auditor role is a key member of the Quality
Assurance team and provides support to all aspects of the Quality functions
across the business. The role will support QA Management in assuring quality
throughout the Company and will promote continual improvement processes to
ensure all systems and procedures undertaken by Care Access are compliant with
ICH-GCP Guidelines, and other applicable regulatory [requirements.
This](http://requirements.This) role encompass a broad spectrum of activities,
ranging from auditing systems and processes to collaborating with stakeholders
and contributing to the organization's overall quality and regulatory
compliance objectives.



 **What You'll Be Working On**  

 **Duties include but not limited to:**  

Conduct audits on quality systems and processes to ensure adherence to company
policies, quality criteria, and applicable regulatory requirements and
industry standards.

Internal routine audits and training to ensure consistency and compliance of
Operations across all sites.

Complex audits, such as For-Cause audits, or process/ system audits at short
notice.

Preparation and hosting external audits (e.g. conducted by Care Access
Clients) and Regulatory Authority Inspections.

Act as the QA SME for Quality Issues. Attend cross-functional meetings and
support Operational Compliance Teams with root cause analysis investigations
(as required).

To work with Care Access personnel to improve and implement globally working
practices and systems, in compliance with GCP and appropriate regulations to
ensure best practices are achieved.

Act as the SME for business process improvement projects (as required).

Review existing quality standards and actively contribute to the development
of programs aimed at enforcing and enhancing these standards.

To be an active part of the Quality Assurance team and work with the other
members to plan and to manage the business, the culture, the values and the
wellbeing of the company and its people so that the commercial objectives are
achieved.

To develop Quality systems, processes and procedural improvements that deliver
increased efficiency and other benefits.

Investigate, analyze, and ensure the accuracy of information in quality data
collection tools, contributing to reliable data-driven decision-making.

Where requested by QA Management, provide effective training, coaching and
mentoring, to junior members of the Quality Assurance department.

Where required, to peer review audit reports.

Conduct reviews of Care Access formal procedures to ensure alignment with
quality standards and regulatory requirements.



 **Physical and Travel Requirements**  

This role requires 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:**  

Knowledge of the Clinical Trial Process

Knowledge of working to Quality systems and procedures in a regulated
environment

Knowledge of international GCP regulations and regulatory inspections

Excellent analytical and communication skills and a proven track record of
interacting with customers and/or suppliers

Computer skills in Microsoft Office applications are essential.  

Be highly organized with a focus on quality and detail

Self-motivated with a high level of initiative

Open and clear communicator with excellent interpersonal skills

Ability to mentor junior staff  Ability to work in a proactive and reactive
environment

Ability to work with complex and difficult situations alone Good problem
solving skills

  

 **Certifications/Licenses, Education, and Experience:**  

BSc Degree (life science) or equivalent qualification

Minimum five years’ experience in Clinical Quality Assurance within a CRO or
Pharma organization or equivalent environment

Experience of performing clinical quality audits e.g. investigator site
audits, process/ system audits, vendor audits.

Experience in validation of Computerized Systems would be an asset.

Experience of regulatory inspections e.g. MHRA, FDA  Experience of sponsor/CRO
audit process

  

 **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 patients 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 patient 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 patients.



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 at this time.

  

 **Employment Statement**

Care Access complies with all employment laws and regulations with respect to
its employment practices, terms and conditions of employment, and pay equity
and wages. Care Access does not engage in any unfair or forced labor practice
and does not tolerate, under any circumstances, the use of any form of forced
or involuntary labor, child labor, or human trafficking. This extends to
suppliers, partners, or other third parties with whom Care Access does
business. Care Access values and promotes the protection of human rights
everywhere.

