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