Global Corporate Auditor

Job Description

Primary Function of Position

The Global Corporate Auditor will support the execution of an efficient and effective Quality audit program. They will support the internal, external, supplier and clinical audit programs to ensure compliance to the applicable regulatory requirements and standards.  This individual will have a clear understanding of applicable laws and regulations in order to identify and manage the company's risks appropriately. They will use Quality Auditing principles, tools and techniques to support quality systems and processes aligned with the overall Company strategy and mission affecting continuous process improvement. They will ensure effective closure of audit findings, by working with cross functional and varying level of departments/business partners to ensure comprehension, development, and execution of corrective/preventive action and evaluation of effectiveness checks. They will assist with gap assessments including working with functional area owners to close regulatory gaps. They will continually educate the organization on effective compliance systems, processes in alignment with applicable laws and regulations. They will support the quality and regulatory improvement projects and provide insight for long-term strategic QMS improvement.

Roles and Responsibilities:

• Conduct internal audits across all global sites.
• May also coordinate internal audits and provide oversight to external contractors.
• Support supplier and clinical audits as assigned.
• Support external audits or regulatory inspections across global sites
• Complete gap assessment for regulations, regulatory standards, and corporate procedures
• Train company employees on Quality System Regulations and quality system foundational principles
• Work together with strategic partners across global sites to assure compliance with all company procedures and regulatory requirements.
• Support Quality System projects for new and changing regulatory requirements Serves as the lead coach/consultant to educate internal customers on regulatory compliance processes and regulations
• Create, approve, and maintain company quality documents, such as quality procedures, work instructions, and forms
• Support CAPA program as audit findings are an input to the CAPA process.
• Review, approve, provide feedback on CAPA documentation as assigned
• Analyzes quality data and provides compliant, pragmatic guidance to support Regulatory Compliance activities including responses to agency requests for information and analyses to support quality improvement projects.
• Prepare responses to regulatory audit observations.
• Ensure that responses are clear, comprehensive, accurate, and well written to mitigate potential for further regulatory actions.
• Provide data to support; Risk based audit schedule, process analysis, process controls, FDA trending and finding history, and needed process improvements activities
• Support implementation and continuous improvement of the audit programs, auditor qualification programs, and company-wide inspection readiness.
• Support, consult, train, and lead quality improvement projects
• Provide Quality System Consultation Support new site integration activities across global sites
• Assist in the development and reporting of Quality System Metrics and KPIs

Qualifications

Required Knowledge, Skills, and Experience:

• ISO certified lead auditor (ISO 9001, ISO 13485 and/or ISO 14155 or ASQ CQA)
• Minimum 2+ years of FDA /ISO 13485 lead auditing experience
• Minimum 5 years of experience in quality in the medical device industry
• Previous experience conducting internal audit is must
• Experience conducting supplier and clinical site audit is a plus
• Quality Engineer, Software Quality and Validation experience is a plus
• Strong knowledge of EU-MDR, ISO 13485:2016; Medical Device Single Audit (MDSAP), and 21 CFR 820 requirements, , Health Canada, and other international regulatory requirements
• Previous experience participating in notified body and FDA inspections
• Familiarity with GMPs related to Combination and Drug Products
• Ability to work on virtual teams, remote management; self-directed
• Ability to be a team player and a partner to the cross- functions teams; be part of the solution and demonstrate ability to use risk-based judgment.
• Critical thinking skills and a passion to work in a fast-paced industry with complex/cutting edge technology
• Strong organizational, written and verbal communication skills, remote working apps and the proven ability to prioritize tasks effectively in a deadline-driven environment

Required Education and Training

• Minimum Bachelor of Science degree in Technical, Engineering or Science related field.