Senior GLP Quality Auditor/Specialist
The Senior GLP (Good Laboratory Practice) Auditor/Specialist is primarily responsible for providing quality consultation, training, auditing and coordination of projects necessary to maintain and improve the quality of work-related processes and new product development programs worldwide.
- Carry out job duties independently, including study-specific inspections, internal system / process based-audits, and external supplier CRO (contract research organization) audits. Requires minimal supervision or direction.
- Independently plan and conduct internal systems audits, external supplier CRO audits and due diligence assessments for merger/acquisition and in-licensing opportunities. Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues.
- Gather internal audit metrics, perform trend analysis and present to management.
- Provide guidance and training on GLP regulations and guidelines for auditors and functional area personnel.
- Collaborate with and assist the Inspection Management group on preparation for and support of inspections by regulatory agencies.
- Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities.
- Elevate issues to management, as necessary, in meeting these responsibilities.
- Lead goals with cross-functional or broader scope and resolve team issues with minimal oversight.
- This is an experienced level quality assurance auditor position. This individual is expected to identify and resolve problems, have effective interpersonal skills, work independently, mentor QA auditors, and also be an effective cross-functional team lead.
- Bachelor's degree, preferably in life sciences or engineering.
- Must have demonstrated strong leadership competencies, broad technical capabilities, and independence.
- 6+ years' experience in function or related fields, such as, toxicology, bioanalytical laboratory, analytical chemistry, clinical pathology, Quality Assurance and/or Regulatory Affairs.
- In-depth knowledge of global GLP/GCP regulatory standards.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and / or Certified Quality Auditor (CQA).