Corporate Compliance Specialist

🌍 Remote, USA 🎯 Full-time 🕐 Posted Recently

Job Description

Company Information

Clinical Ink is the global life science company that brings data, technology, and patient science together to unlock clinical discovery. Our deep therapeutic-area expertise, coupled with Direct Data Capture, eCOA, eConsent, telehealth, neurocognitive testing, and digital biomarkers advancement, drive the industry standard for data precision and usher in a new generation of clinical trials. With offices in the United States and Denmark, Clinical Ink is rewriting the clinical development experience.

Job Description

Support the vendor qualification, risk assessment, and ongoing monitoring process in accordance with approved Vendor Management SOPs.
Assist with planning, conducting, and documenting vendor audits, assessments, and re‑qualifications based on risk and business criticality.
Maintain vendor audit records, reports, and evidence to ensure inspection and audit readiness.
Track and monitor vendor CAPAs, commitments, and remediation activities, including effectiveness checks and closure verification.
Support cross‑functional stakeholders (IT, Security, Product, Legal, Procurement) in supplier evaluations, including review of compliance documentation (e.g., certifications, audit reports, questionnaires).
Assist in maintaining and updating vendor‑related customer communications, including RFI responses and audit questionnaires.
Support the planning, execution, documentation, and follow‑up of internal audits against Clinical Ink’s QMS, SOPs, and applicable regulations.
Document internal audit observations, nonconformances, and improvement opportunities in the Quality Event (QE) system.
Monitor and progress CAPA activities resulting from internal audits, vendor audits, deviations, and other quality events.
Perform effectiveness checks to confirm sustained compliance and risk mitigation.
Maintain internal audit schedules, reports, and supporting evidence to ensure continuous audit readiness.
Administer the corporate LMS in alignment with the approved Training Matrix and role‑based requirements.
Coordinate with Human Resources and department leaders to ensure timely and compliant training assignments, onboarding, and retraining.
Assist in the development, revision, and implementation of quality and compliance policies and procedures.
Collaborate with internal stakeholders to promote a culture of quality, accountability, and compliance.
Support continuous improvement initiatives related to vendor management, audit execution, and quality system effectiveness.
Perform other compliance‑related duties and special projects as assigned.

Bachelor’s degree required. Minimum 5+ years of experience in quality, regulatory compliance, vendor management, or audit support within a regulated industry (pharmaceutical, biotech, medical device, or GxP software preferred).
Working knowledge of FDA Quality System regulations, 21 CFR Part 11, EU Annex 11, and global GxP expectations preferred.
Experience supporting vendor audits, internal audits, CAPA management, and quality events strongly preferred.
Excellent written and verbal communication skills, with the ability to interact effectively across all organizational levels.
Strong organizational, time‑management, and documentation skills with attention to detail.
Ability to manage multiple priorities in a fast‑paced, regulated environment.

Additional Information

Clinical Ink is an equal opportunity employer and does not discriminate against otherwise qualified applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or handicap, or veteran status.

www.clinicalink.com

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