CMC Auditor

Job Description
Responsibilities
• Maintain an expert level of knowledge related to GMP requirements and industry trends as described in applicable worldwide regulations
• Advise supported areas on requirements for all assigned project responsibilities as related to quality and communicate project status to management
• Independently audit applicable regulatory filings. Ensure compliance with regulatory requirements. Work with areas to resolve any audit findings.
• Identify training needs and oversee, develop and/or conduct training or orientation sessions for internal staff and client groups as well as staying current with own training requirements
• Identify need for and/or develop SOPs to ensure practices are accurately reflected
• Represent CMC Auditing on inter-departmental and cross-functional teams, ensuring the flow of information and providing quality guidance
• Independently prioritize activities in support of multiple projects
• Support preparations for regulatory agency inspections
• Support other functional area and departmental priorities, as needed
Lead Auditor Requirements include:
• Foster collaboration, drive results, make rapid disciplined decisions
• Demonstrate excellent organization skills
• Effectively manage multiple projects, and delegate audits to support team/auditors. Request additional resources as necessary.
• Maintain positive working relationships within CMC Auditing team and client areas
• Share and apply lessons learned
• Hold self and other accountable
• Clear communication skills (express in a clear, concise manner)
• Demonstrate interpersonal skills to effectively lead an audit
• Attend Project Team Meetings
• Act as a single point of contact
• Keep close track of submission timelines and meet deadlines while still maintaining all audit goals
• Identify and manage issues on a continuous basis (e.g. unacceptable source documents, late submission of audit documents, delay in comments resolution that impacts submission time lines)
• Provide guidance to the project teams in specific situations in terms of sources, audit maps, and workflows
• Update the auditing team with changes in Submission Timelines, or other changes (Specifications, Methods, etc.)
• Prioritize audit sections based on CMC request
• Effectively listen to the auditee and seek to understand differing perspectives to resolve audit issues
Specific and/or additional duties may include, but are not restricted to:
• Provide tracking, trending and metrics for CMC Auditing activities
• Provide technical guidance to senior management in evaluating systems/tools
• Assist CMC Auditing staff and client areas with the technical aspects related to the use of electronic audit tools
• Support Process Improvement initiatives for CMC client and auditing area