DSV - Global Transport and Logistics · 5 hours ago
Compliance Manager, Healthcare
Indianapolis, IN
Full-time
Remote
Mid, Senior Level
$78K/yr - $118K/yr
5+ years exp
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Responsibilities
Govern regulatory and operational execution of the Healthcare Quality program aligned with industry regulations and company policies for the assigned network branches and respective warehouse locations.
Manage the Healthcare Quality Programs for assigned region network branches including but not limited to: Change Control, Training as applicable, Training Matrix, Signatory requirements, and record retention.
Monitor and assess compliance risks and identify areas for improvement.
Liase with US QHSE to ensure healthcare branches are current on all ISO requirements as they relate to Healthcare
Conduct regular internal audits and reviews to ensure compliance with applicable laws, regulations, and internal policies as per Group Guidelines
Provide guidance and training to employees on Healthcare Quality and Operational matters.
Collaborate with internal stakeholders to continually improve execution of compliance strategies.
Investigate and address compliance-related incidents, violations, and complaints by conducting trend analysis of Nonconformance incidents
Lead and support internal investigations and audits related to compliance.
Develop and maintain effective compliance-related documentation and record-keeping as per Group Guidelines
Lead and/or assist in external client audits – ensuring a successful audit
Ensure branch performance is in line with internal KPIs for risk assessments, timely completion of nonconformance requirements
Ensure all audits are well prepared, to limit findings and also respond to any findings as per the guidelines for Nonconformances
Perform, manage, and close subcontractor audits as required
Confirm responsibility and job roles of the Healthcare QMS Quality Lead and Auditor
Other duties as assigned
Qualification
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Required
Auditor certification is required
Knowledge in Quality Management infrastructure is required – external accredited training is a plus
Minimum of 5-7 years of experience in Healthcare compliance management, preferably in the transportation and logistics industry
Strong knowledge of applicable FDA regulations for the internal transport is required (controlled substances)
Experience in implementing and governing compliance programs and policies
Proven track record of managing compliance-related audits and investigations
In-depth understanding of transportation and logistics industry regulations
Strong knowledge of Healthcare compliance frameworks and best practices
Excellent analytical and problem-solving abilities
Strong leadership and project management skills
Excellent communication and interpersonal skills
Ability to collaborate and influence at all levels of the organization and cross functionally
Exceptional attention to detail and organizational skills
Familiarity with risk assessment and mitigation techniques
Proficiency in data analysis and reporting
Fluent in English (oral and written)
Proficient in using Validaide, PowerBI, Cargowise One, and Quality Integrated Management software and tools
Advanced knowledge of Microsoft Office suite
Ability to adapt to new technology platforms used in compliance management
Preferred
Advanced degree in business administration, or a relevant discipline
Operational knowledge of Freight Forwarding is strongly encouraged
May have supervisory responsibilities (either direct or indirect) guiding a team of Healthcare Operations professionals
Certification in Healthcare Compliance QMS Program
External Auditor or other ISO related certifications preferred and encouraged
Strong understanding of US Regulatory Healthcare Requirements as defined in Code of Federal Regulations
Experience working with US FDA, DEA, IATA, etc
Experience managing compliance programs in a global organization
Familiarity with compliance management software and tools
Knowledge of industry-specific certifications, such as C-TPAT, AEO, or ISO
Company
DSV - Global Transport and Logistics
At DSV, we keep supply chains flowing in a world of change.
10,001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$6.05B2024-10-04Post Ipo Equity· $5.51B
2024-06-26Post Ipo Debt· $535.5M
2002-06-28IPO· cph:DSV
Leadership Team
Jens Bjørn Andersen
Group CEO
Recent News
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