The Senior Auditor, WW Regulatory Compliance is responsible for conducting compliance audits at company facilities on a worldwide basis. Responsibilities include planning and conducting assigned audits of specific sites, products, processes, or areas to assess compliance status with applicable regulations, standards and internal requirements. Supports manufacturing sites with training and guidance in establishing best practices.
* Adhere to and follow Haemonetics policies and procedures and apply function related applicable regulatory requirements.
* Assist in development of annual audit schedule. Assist leaders of regulatory and quality with department activities such as monthly reports, external communications, etc.
* Assist in FDA and other regulatory inspections, including 3rd party audit/inspection readiness activities.
* Audit results reporting, analysis and presentation of audit of findings.
* Build quality into all aspects of work by maintaining compliance to all quality requirements.
* Ensure company adherence to Haemonetics policies and procedures.
* Lead, plan and conduct scheduled global compliance and quality system audits to assess compliance with FDA regulations, ISO standards, MDD, and other applicable regulatory and internal requirements, encompassing both Medical Device and Pharmaceutical Good Manufacturing Practices, individually or as part of a team.
* Mentor and assist in the training and development of quality compliance and manufacturing site employees.
* Participate in planning, coordination, and implementation of global compliance audit policies with corporate and business leaders.
* Participate in quality improvement and compliance projects as required.
* Participate in the development and delivery of communication and training activities and quality and compliance forums within the company and externally.
* Perform follow-up actions with auditees to perform audit close out.
* Serve as a consultant by providing expert guidance and meaningful interpretations of applicable regulations and industry best practices to the organization.
* Serve on project teams to support compliance and quality improvement initiatives.
* The incumbent may be asked to perform other function-related activities in addition to the above mentioned responsibilities as reasonably required by business needs
Required Bachelor’s Degree
Required 8 years Experience in quality and regulatory for medical devices and/or pharmaceuticals
Required 5 years Experience in Compliance Auditing in the medical device, pharmaceutical industry, and/or a comparable regulated environment
Required Other Equivalent combination of education and experience
Licenses and Certifications:
Preferred Certified auditor or lead auditor training
Required Training in Audit techniques
Required Knowledge of MS Word, Excel, PowerPoint, MS Outlook, and general database experience
Required Ability to travel internationally
Candidate Background: Skills, Knowledge & Ability: Minimum requirements:
Required Experience in quality and regulatory for medical devices and/or pharmaceuticals
Required Experience in Compliance Auditing in the medical device, pharmaceutical industry, and/or a comparable regulated environment
Required Equivalent combination of education and experience