Quality Assurance Compliance Specialist

Who You Are: You are a quality-focused clinical research professional who enjoys working collaboratively across teams and takes pride in ensuring compliance, consistency, and continuous improvement. You thrive in a fast-paced environment, are comfortable wearing multiple hats, and are excited by the opportunity to make a visible impact within a growing organization focused on advancing research in Parkinson's disease and other neurological disorders. Ideal backgrounds include academic research institutions, CROs, sponsors, biotechnology or pharmaceutical companies, and other GCP-regulated clinical research environments.

Why You’ll Love This Role: You'll play a visible role in advancing research focused on Parkinson's disease and other neurological disorders while gaining broad exposure across all aspects of Quality Assurance. In this highly collaborative position, you'll partner across the organization, take ownership of meaningful work, and help shape quality processes within a growing clinical research organization.

What You’ll Do:

· Support compliance and quality assurance activities across IND clinical research programs and operational functions, ensuring adherence to applicable regulatory requirements, company policies, and quality standards.

· Assist in the development, implementation, maintenance, and continuous improvement of quality systems, processes, and procedures.

· Support quality and compliance investigations, including D&T incidents, root cause analysis, and CAPA management.

· Author, review, revise, and maintain Standard Operating Procedures (SOPs), work instructions, forms, templates, and other controlled documents.

· Manage company-side administration of IND's Learning Management System (LMS), including training assignments, completion monitoring, reporting, and training record maintenance.

· Support vendor qualification, audit, inspection, and compliance review activities, including documentation review, tracking observations, and supporting corrective action follow-up.

· Support quality and compliance activities for myPPMI and other IND research programs, including compliance tracking, documentation management, training oversight, and continuous improvement initiatives.

· Maintain quality records, compliance logs, metrics, dashboards, and tracking systems to support organizational oversight and reporting.

· Collaborate with cross-functional teams, including Clinical Operations, Research Program Operations, Data & Technology, IND Clinic and Regulatory Affairs, to support quality and compliance initiatives.

· Support data privacy, security, and regulatory compliance activities, including Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and applicable data protection requirements, while participating in continuous improvement initiatives to enhance compliance and operational effectiveness. in continuous improvement initiatives to enhance compliance and operational effectiveness.

Qualifications/Requirements:

· Bachelor's degree in Life Sciences, Public Health, Healthcare Administration, Clinical Research, Quality Management, or a related field required.

· Minimum of three (3) years of experience in quality assurance, regulatory compliance, clinical research, healthcare, or another regulated environment.

· Working knowledge of Good Clinical Practice (GCP), FDA regulations, ICH guidelines, and quality management principles.

· Experience supporting audits, inspections, training programs, document control, SOP management, vendor qualification activities, or compliance initiatives preferred.

· Proficiency with Microsoft Office applications and experience working with learning management systems (LMS), document management systems, or quality management systems preferred.

· Demonstrated ability to work independently in a remote environment while maintaining accountability for deliverables, deadlines, and quality standards; adaptable to changing priorities and a fast-paced clinical research environment.

· Strong organizational, problem-solving, communication, and interpersonal skills, with the ability to manage multiple priorities, collaborate effectively across departments, and build productive relationships in a matrixed organization.

· Ability to work 100% Remote

· Periodic travel may be required (<10%).

Beyond the Job

At IND, we believe that when our people are supported, they can do their best work. We’re committed to taking care of our team so they can focus on the important work of advancing research. In addition to joining a mission-driven, innovative team with a collaborative and inclusive culture, you will also enjoy:

• Competitive base salary: $90k - $110k (D.O.E.)

• Bonus eligible

• Medical, dental, and vision Insurance

• Flexible Spending Accounts (FSA)

• Employer-paid life and disability insurance

• Paid time off: Flexible vacation, sick and holidays

• Contribution to retirement plan (403b)

• Professional development opportunities

• 100% remote work with opportunities for in-person company events

Who We Are: We are The Institute for Neurodegenerative Disorders (IND), founded in 2000, an independent 501(c)(3) nonprofit research institute based in New Haven, CT. We are committed to advancing research, diagnosis, and treatment of neurodegenerative diseases. We’re proud to be part of the Parkinson’s Progression Markers Initiative (PPMI), a landmark program launched in 2010 in collaboration with The Michael J. Fox Foundation for Parkinson’s Research. PPMI has achieved unprecedented growth, expanding to over 50 global clinical sites with 4000+ participants. Learn more about us: https://www.indd.org/

IND is an equal opportunity employer. We encourage applications from individuals who will help us build and sustain a diverse, equitable, and inclusive workplace. Diversity may include, but is not limited to, race, religion, ethnicity, sex, gender identity, sexual orientation, socioeconomic background, geographic origin, ability and disability, political beliefs, and age. We value the unique perspectives and experience each team member brings to advancing our mission.