Manager, Quality Assurance
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
How This Role Makes a Difference
The Manager, Quality Assurance plays a critical role in advancing our fundamental commitment of accelerating
access to new medicines and health screenings while meeting our own high standards. Supporting Care
Access and Reify Health, this role drives quality management system activities including auditing, inspection
readiness and audit and inspection support, vendor review and qualification, SOP development and review,
investigation of quality events, root cause analysis, and CAPA management, and training, continuous
improvement or quality-by-design initiatives, and support for RFPs/RFIs.
This role helps ensure that patient safety, data integrity, regulatory compliance, and continuous improvement
are embedded in everything we do. Quality at Care Access is built on strong systems and even stronger
accountability, supported by both embedded quality support and independent quality auditing and oversight,
comprehensive SOPs and training, robust quality control, and a proactive CAPA framework that identifies,
corrects, and prevents issues at their source.
The Manager, Quality Assurance partners across the organization to strengthen inspection readiness and
contributing to a global culture where quality is a personal mandate and continuous improvement is expected.
By enabling consistent compliance with global regulatory standards, ICH guidelines, and internal procedures,
this role helps ensure that every study is conducted with rigor, transparency, and a shared commitment to
delivering high-quality clinical research that improves lives.
How You'll Make An Impact
Duties include but are not limited to:
- Internal Auditing: independently lead and conduct internal audits and related GxP activities including Investigator site audits, process audits, vendor qualifications, vendor audits, and other specialized audits or quality investigations as defined by leadership.
- External audits: provide quality and compliance support on sponsor audits, client audits, and regulatory inspections.
- Quality Issue/CAPA management: support RCA/CAPA development, tracking, and completion. Works with department to implement and verify CAPAs. Evaluate audit findings, review Quality Issue classification, and review documentation related to QI management. Perform effectiveness checks.
- Documentation and reporting: Produce clear and evidence-based quality systems documentation. Display report writing capabilities and an ability to work within timelines. Be organized and capable of demonstration of ALCOAC. Review informed consent forms, investigator site files, and source documents for accuracy.
- Inspection readiness: promote a culture of inspections readiness and continuous improvement. Be flexible to work with risk-based audit agendas and shifting priorities.
Other Responsibilities:
- Regulatory compliance: be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidances such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3).
- Create and deliver training on Quality and Continuous Improvement activities
- Support completion of RFP/RFI (Request for proposals/information)
- Learn and engage with digital technologies, including artificial intelligence
- Support drafting for or conduct quality reviews of SOPs and provide support of SOP management
- Provide AI project quality support, QC and consultation
- Support other activities related to the management of QMS and accuracy of data
- Support GxP and non GxP quality issues and/or projects needing quality consultation and support
The Expertise Required
- Ability to work independently, remain objective, and manage multiple assignments and competing priorities.
- Ability to remain flexible and work in evolving regulatory environments and understand different quality frameworks for different programs or service lines across our company portfolios.
- Strong communication skills to develop collaborative working relationships and support sponsor, client or regulatory communications to enhance the impact of quality support.
- Strong interest in clinical research and health services, including knowledge of clinical trial site operations, protocol deviation management, regulatory frameworks and sponsor perspectives.
- Display an openness to innovative and compliant approaches to conducting research and health services activities.
- Ability to prioritize business objectives while maintaining high attention to detail.
- Technical proficiency required to work daily in eQMS and utilize various software and platforms across the business.
- Ability to communicate written and verbally and communicate findings effectively to senior leaders.
Certifications/Licenses, Education, and Experience
- A bachelor’s degree is preferred with a minimum of 1-3 years’ experience in clinical research-related quality assurance or compliance roles or clinical auditing. Years of experience in clinical research-related roles may be substituted for degree requirements on a year-per-year basis. Site experience is valued.
- Clinical trial experience for a site, site network or CRO is required.
- Knowledge of GCP auditing techniques is preferred but may be transferable through other work experiences across GxP auditing, quality control, or five or more as a clinical research coordinator with quality related experiences.
- Certification as a clinical auditor is a plus but not required.
How We Work Together
- Location: This role requires most of the work be performed in a remote or office environment.
- Travel: This role requires up to 35% of domestic and/or international travel. Length of travel will depend upon business requirements, staff needs, and company initiatives.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
The expected salary range for this role is $85,000 - $110,000 USD per year for full time team members.
Benefits & Perks (US Full Time Employees)
- Paid Time Off (PTO) and Company Paid Holidays
- 100% Employer paid medical, dental, and vision insurance plan options
- Health Savings Account and Flexible Spending Accounts
- Bi-weekly HSA employer contribution
- Company paid Short-Term Disability and Long-Term Disability
- 401(k) Retirement Plan, with Company Match
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we 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 are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, 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.
If you need an accommodation to apply for a role with Care Access, please reach out to: TalentAcquisition@careaccess.com
Mandatory Employer Disclosures:
Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.
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