As a member of the Global Supplier Quality organization, the Auditor will be responsible for performing external supplier audits, assessing supplier capabilities, assessing and mitigating supplier risk and maintaining corporate Supplier Quality standards.
The candidate will work closely with Global and site Quality, Global and Site Procurement, and Site Operations to develop an annual audit plan that ensures continued qualification of all external suppliers. The candidate will work with the other global auditors to assign and conduct the required annual supplier audits and will work with suppliers to identify and implement CAPAs that resolve findings from the audit. The candidate will display expertise in various standards and regulations such as cGMP, ISO, CFR 21, EudraLex, ICH Q7, etc.
- Travel 50% +
- Conduct external supplier audits
- Perform supplier capability assessments
- Provide oversight of the Corporate Supplier Management plan, Audit & Reevaluation schedule
- Knowledge of applicable Quality Standards, related Regulatory requirements and best practices
- Understanding both receiving site and supplier procedures and practices
- Adherence to timelines regarding availability of audit reports and other critical documents
- Act as the liaison between Suppliers in their region and the internal sites
- Collaborate with site management and global/site Procurement teams
- Bachelor’s Degree is required in Chemistry, Engineering, Microbiology, or Biology
- 5-10 years of relevant experience in a GMP environment, in any of the following industries: Pharmaceutical, Medical Device, OTC Drug, Cosmetic and/or Food and Dietary Supplements, is required
- Minimum of 3 years auditing experience required including supplier auditing experience
- Experience working with internal or external partners to drive compliance, CAPA completion to audit findings, and/or performance improvement is required.
- Experience in CAPA management systems (i.e. TrackWise)
- Experience in a matrix organization
- Knowledge of cGMPs, Quality System standards and regulatory requirements such as 21 CFR, ICH Q7, EXCIPACT, IPEC, ISO 9001, etc.
- Ability to evaluate suppliers to different quality systems standards.
- Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
- Effective written, interpersonal, and presentation skills.
- Ability to work on multiple projects simultaneously.
- Ability to travel up to 50% of the time.
- Strong time management skills and the ability to work within a team as well as independently.