Sr Auditor Clinical Quality Audit
Sr Auditor Clinical Quality Audit
Posted on :
22-04-2025
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1 Vacancy
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Job Description
- Assure quality and compliance in a regulated environment that includes worldwide regulations country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of Clinical processes through audit and QA oversight activities.
- Take a lead in the Clinical audit program by planning and executing all types of clinical audits and working with auditees to resolve any noncompliance identified. Regularly leads more complex/challenging audits.
- Lead/contribute to riskbased assessments to identify potential audits.
- Advance the AbbVie Quality System through leading and/or contributing to the development and implementation of systems and processes required to support global quality assurance requirements.
- Contribute to continuous improvement initiatives/projects to help assure compliance to regulations and corporate policies.
- May act as Audit Lead/SME for an assigned audit type. Responsible for maintaining standards including tools/templates and guidance documents and participates in onboarding new auditors for that audit type.
- Mentor coach and train Clinical Audit staff.
- Participate in and supports GCP inspections as required.
- Recognised as a SME; provides support and consultation to RDQA and business partners with regards to Clinical Quality and GCP regulations.
Qualifications :
- Bachelors degree in science (physical life health) a health care profession (e.g. nursing or pharmacy) or equivalent experience
- 35 years of experience in the biopharmaceutical industry (Quality Assurance and/or Clinical Research Development) or with a regulatory authority
- 35 years of experience in Clinical Quality Assurance or equivalent area
- Strong analytical skills and the ability to draw conclusions from presented data
- Ability to work effectively and efficiently promote a dynamic environment with minimal supervision
- High level of awareness and understanding of clinical trial regulations (e.g. ICHGCP EU Clinical Trial Directive/Regulation) and industry best practices
- Flexibility to adapt to changing assignments and ability to effectively prioritize
- Good project management interpersonal and communication skills with ability to work independently and as part of a team
- Willingness and ability to perform international travel
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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Employment Type :
Fulltime
Employment Type
Full-time
Key Skills
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