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Senior Compliance Auditor

The Senior Compliance Auditor is an exciting role focused on meeting our commitments to the patients we serve by ensuring that Catalent and our suppliers are compliant with company and customer standards in addition to standards set forth by regulatory agencies.   This role will allow you to work closely with suppliers and collaborate with other departments to ensure that we consistently and reliably produce safe, reliable, and high quality pharmaceutical products. The Role Manage, lead, and conduct audits, including risk assessments, scheduling, preparing documents prior to the audit, creating PRs in TrackWise, and managing audits during execution and closure Lead preparations for planned Health Authority Inspections Coordinate and respond to Supplier Audit Responses; discuss observations with site leadership to determine or evaluate corrective actions and responses; track and report on implementation of corrective actions Lead investigative teams for supplier non-compliance and/or disqualification The Candidate Minimum of a Bachelor's degree in a science field or equivalent education and job experience Experience leading Supplier Audits, writing Supplier Audit reports, and ensuring corrective actions are implemented and adhered to Minimum 7 years of experience in an FDA regulated industry with progressively increasing responsibilities      Experience interacting with Health Authority Agencies Knowledge of ICH, Q8, Q9 and Q10 Knowledge of US and EU cGMP Regulations Catalent's standard leadership competencies that are used to interview and for Performance & Development Leads with Integrity and Respect Delivers Results Demonstrates Business Acumen Fosters Collaboration and Teamwork Champions Change Engages and Inspires Coaches and Develops Position Benefits Potential for career growth within an expanding team Defined career path and annual performance review & feedback process Cross functional exposure to other areas of Manufacturing and Operations Medical, Dental, Vision, and 401K are all offered from day one of employment 152 hours of paid time off annually + 7 paid holidays
Salary Range: NA
Minimum Qualification
8 - 10 years

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