Corporate Compliance Specialist
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
Clinical Ink is seeking a Corporate Compliance Specialist to join our remote Compliance team! The Corporate Compliance Specialist will be largely responsible for vendor management and internal audits. The ideal candidate will have experience in quality, regulator compliance, vendor management, and audit support within a regulated industry (pharmaceutical, biotech, medical device, or GxP software preferred). The Corporate Compliance Specialist's responsibilities will include:
ā¢ Support the vendor qualification, risk assessment, and ongoing monitoring process in accordance with approved Vendor Management SOPs.
ā¢ Assist with planning, conducting, and documenting vendor audits, assessments, and reāqualifications based on risk and business criticality.
ā¢ Maintain vendor audit records, reports, and evidence to ensure inspection and audit readiness.
ā¢ Track and monitor vendor CAPAs, commitments, and remediation activities, including effectiveness checks and closure verification.
ā¢ Support crossāfunctional stakeholders (IT, Security, Product, Legal, Procurement) in supplier evaluations, including review of compliance documentation (e.g., certifications, audit reports, questionnaires).
ā¢ Assist in maintaining and updating vendorārelated customer communications, including RFI responses and audit questionnaires.
ā¢ Support the planning, execution, documentation, and followāup of internal audits against Clinical Inkās QMS, SOPs, and applicable regulations.
ā¢ Document internal audit observations, nonconformances, and improvement opportunities in the Quality Event (QE) system.
ā¢ Monitor and progress CAPA activities resulting from internal audits, vendor audits, deviations, and other quality events.
ā¢ Perform effectiveness checks to confirm sustained compliance and risk mitigation.
ā¢ Maintain internal audit schedules, reports, and supporting evidence to ensure continuous audit readiness.
ā¢ Administer the corporate LMS in alignment with the approved Training Matrix and roleābased requirements.
ā¢ Coordinate with Human Resources and department leaders to ensure timely and compliant training assignments, onboarding, and retraining.
ā¢ Assist in the development, revision, and implementation of quality and compliance policies and procedures.
ā¢ Collaborate with internal stakeholders to promote a culture of quality, accountability, and compliance.
ā¢ Support continuous improvement initiatives related to vendor management, audit execution, and quality system effectiveness.
ā¢ Perform other complianceārelated duties and special projects as assigned.
Qualifications
ā¢ Bachelorās 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).
ā¢ Working knowledge of FDA Quality System regulations, 21 CFR Part 11, EU Annex 11, and global GxP expectations preferred.
ā¢ Experience supporting vendor audits, internal audits, CAPA management, and quality events strongly preferred.
ā¢ Excellent written and verbal communication skills, with the ability to interact effectively across all organizational levels.
ā¢ Strong organizational, timeāmanagement, and documentation skills with attention to detail.
ā¢ Ability to manage multiple priorities in a fastāpaced, 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 ā
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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
Clinical Ink is seeking a Corporate Compliance Specialist to join our remote Compliance team! The Corporate Compliance Specialist will be largely responsible for vendor management and internal audits. The ideal candidate will have experience in quality, regulator compliance, vendor management, and audit support within a regulated industry (pharmaceutical, biotech, medical device, or GxP software preferred). The Corporate Compliance Specialist's responsibilities will include:
ā¢ Support the vendor qualification, risk assessment, and ongoing monitoring process in accordance with approved Vendor Management SOPs.
ā¢ Assist with planning, conducting, and documenting vendor audits, assessments, and reāqualifications based on risk and business criticality.
ā¢ Maintain vendor audit records, reports, and evidence to ensure inspection and audit readiness.
ā¢ Track and monitor vendor CAPAs, commitments, and remediation activities, including effectiveness checks and closure verification.
ā¢ Support crossāfunctional stakeholders (IT, Security, Product, Legal, Procurement) in supplier evaluations, including review of compliance documentation (e.g., certifications, audit reports, questionnaires).
ā¢ Assist in maintaining and updating vendorārelated customer communications, including RFI responses and audit questionnaires.
ā¢ Support the planning, execution, documentation, and followāup of internal audits against Clinical Inkās QMS, SOPs, and applicable regulations.
ā¢ Document internal audit observations, nonconformances, and improvement opportunities in the Quality Event (QE) system.
ā¢ Monitor and progress CAPA activities resulting from internal audits, vendor audits, deviations, and other quality events.
ā¢ Perform effectiveness checks to confirm sustained compliance and risk mitigation.
ā¢ Maintain internal audit schedules, reports, and supporting evidence to ensure continuous audit readiness.
ā¢ Administer the corporate LMS in alignment with the approved Training Matrix and roleābased requirements.
ā¢ Coordinate with Human Resources and department leaders to ensure timely and compliant training assignments, onboarding, and retraining.
ā¢ Assist in the development, revision, and implementation of quality and compliance policies and procedures.
ā¢ Collaborate with internal stakeholders to promote a culture of quality, accountability, and compliance.
ā¢ Support continuous improvement initiatives related to vendor management, audit execution, and quality system effectiveness.
ā¢ Perform other complianceārelated duties and special projects as assigned.
Qualifications
ā¢ Bachelorās 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).
ā¢ Working knowledge of FDA Quality System regulations, 21 CFR Part 11, EU Annex 11, and global GxP expectations preferred.
ā¢ Experience supporting vendor audits, internal audits, CAPA management, and quality events strongly preferred.
ā¢ Excellent written and verbal communication skills, with the ability to interact effectively across all organizational levels.
ā¢ Strong organizational, timeāmanagement, and documentation skills with attention to detail.
ā¢ Ability to manage multiple priorities in a fastāpaced, 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 ā
Apply tot his job
Apply To this Job