Senior Specialist, Quality Assurance Clinical Auditor

·         A minimum of a Bachelor's degree is required.

Experience and Skills

Required:

·         A minimum of 5 years of related work experience in auditing, clinical operations, or other key related area

·         Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology.

·         Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g. FDA regulations, EU CTR, ICH E6 R2

·         Experience conducting Clinical Quality Assurance audits or assessments of clinical investigator sites, studies, or systems

·         Understanding of fundamentals of clinical trial risk management.

·         Broad knowledge of management of standard operating procedures, good documentation practices, and records management.

·         Digital literacy & Analytics - Experience using standard applications/systems & data analytics tools.

·         Ability to plan and prioritize work in an efficient manner, and to work well under time constraints.

·         Flexibility to respond to changing business needs.

 Preferred:

·         Familiarity with new and emerging technologies and analytics, and the ability to see opportunities where creative capabilities may be applied within QA audit processes

·         Ability to interpret global regulatory standards.

·         Inspection support experience (FDA, EMA and other inspectorates).

·         Conflict resolution/management skills.

·         Strong networking and relationship building skills.

·         Experience balancing multiple projects simultaneously.

Other:

·         Must be able to speak and write in English.

·         This position may require up to 30% domestic and/or international travel.

If you are under 18 years of age, you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check.

·          Independently leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.

·         Ensures the relevant standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.

·         Analyzes, interprets data and identifies patterns and trends in data sets.

·         Ensures timely and appropriate review & delivery of CAPAs and actions arising from audits.

·         Presents information logically and concisely, both verbally and in writing, including writing reports with clarity

·         Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans)

·         Supports regulatory inspections in various supporting roles.

·         Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.

·         May assist in the preparation of training material if requested.

·         Participates in projects or serves on teams, as assigned by supervisor.

·         Meets priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.