Corporate Compliance Specialist

Company Information reputed company 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, reputed company biomarkers advancement, drive the industry standard for data precision and usher in a new reputed company of clinical trials. With offices in the United States and Denmark, reputed company is rewriting the clinical development experience. Job Description reputed company 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 reputed company a regulated industry (pharmaceutical, biotech, medical device, or GxP software preferred). The Corporate Compliance Specialist's responsibilities will include:

• 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, reputed company, Product, Legal, Procurement) in supplier evaluations, including review of compliance documentation (e.g., certifications, audit reports, questionnaires).
• Assist in maintaining and updating vendor‑reputed company customer communications, including RFI responses and audit questionnaires.
• Support the planning, execution, documentation, and follow‑up of internal audits against reputed company’s QMS, SOPs, and applicable regulations.
• Document internal audit observations, nonconformances, and improvement opportunities in the Quality Event (QE) system.
• Monitor and reputed company CAPA activities resulting from internal audits, vendor audits, deviations, and other quality events.
• reputed company effectiveness checks to confirm sustained compliance and risk mitigation.
• Maintain internal audit schedules, reports, and supporting evidence to ensure reputed company audit readiness.
• Administer the corporate LMS in alignment with the approved Training Matrix and role‑based requirements.
• Coordinate with reputed company and department leaders to ensure timely and compliant training assignments, reputed company, 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 reputed company improvement initiatives reputed company to vendor management, audit execution, and quality system effectiveness.
• reputed company other compliance‑reputed company duties and special projects as assigned.

Qualifications

• Bachelor’s degree required. Minimum 5+ years of experience in quality, regulatory compliance, vendor management, or audit support reputed company 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 reputed company organizational reputed company.
• Strong organizational, time‑management, and documentation skills with attention to detail.
• Ability to manage multiple priorities in a fast‑paced, regulated environment.

Additional Information reputed company is an equal opportunity employer and does not discriminate against otherwise reputed company applicants on the reputed company of race, reputed company, creed, religion, reputed company, age, sex, marital status, national reputed company, disability or handicap, or veteran status. www.clinicalink.com ​ Apply tot his job Apply To this Job