QA Audit Manager- (GCP)
- Oversees designated global audit programs for compliance to the master audit plan (procedures, execution, QC, compliance to process, etc.)
- Identifies the scope and leads global audits and associated audit team
- Facilitates prioritization of global projects for risk-based audits
- Ensure the consistent implementation, use and review of SOPs
- Escalate issues to management in a timely manner implementing appropriate solutions, including preventative actions
- Negotiate with functional and operational internal stakeholders to improve quality and increase efficiencies
- Analyze and interpret data in order to lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
- Lead and effectively manage constructive crucial interactions with clients or regulatory agencies
- Lead functional process improvement initiatives to drive efficiencies and effectiveness of Regulatory Compliance & Quality Assurance (RC&QA) processes
- Interpret applicable quality regulations/standards and create appropriate policies and procedures
- Ensure Regulatory Compliance and Quality Assurance (RC&QA) management responsibilities, as indicated in applicable controlled documents, are followed
- Perform other duties, as assigned by management
- A minimum of a Bachelor's Degree in Life Sciences preferred (or equivalent Life Science experience).
- Experience may be substituted for education.
- 8 years in a GCP regulatory environment.
- Experience & regulatory expertise of industry quality systems/standards.
- Experience with hosting internal, external and FDA audits.
- Ability to interpret applicable regulations/standards.
- Experience in leading process improvement initiatives.
- Ability to communicate and negotiate internal stakeholders effectively.
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